Last update 01 Nov 2024

Lutikizumab

Last update 01 Nov 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Bispecific antibody

Synonyms

Immunoglobulin, anti-(interleukin 1.beta./interleukin 1.alpha.) (synthetic human a-1234138 heavy chain), disulfide with synthetic human a-1234138 light chain, dimer, lutikizumab, A-1234138

+ [1]

Target

IL-1α x IL-1β

Mechanism

IL-1α inhibitors(Interleukin-1 alpha inhibitors), IL-1β inhibitors(Interleukin-1 beta inhibitors)

Therapeutic Areas

Infectious DiseasesSkin and Musculoskeletal DiseasesOther Diseases+ [4]

Active Indication

Hidradenitis SuppurativaCrohn DiseaseDermatitis, Atopic+ [2]

Inactive Indication

Osteoarthritis, Knee

Originator Organization

AbbVie, Inc.

Active Organization

AbbVie, Inc.

Inactive Organization-

Drug Highest PhasePhase 3

First Approval Date-

Regulation-

Gene Sequence

Sequence Code 9550995H

Source: *****

Sequence Code 9551004L

Source: *****

Clinical Trials associated with Lutikizumab

NCT06548542 / RecruitingPhase 2

A Phase 2a Multicenter, Randomized, Platform Study of Targeted Therapies for the Treatment of Adult Subjects With Moderate to Severe Crohn's Disease

Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most frequently affecting the bowels. It can cause many different symptoms including belly pain, diarrhea, tiredness, and weight loss. Treatments are available but do not work the same for all patients or may stop working over time. This study will evaluate the effectiveness and adverse events of targeted therapies (TaTs) for adult participants with moderate to severe CD.
The medicines assessed in this study are risankizumab, ABBV-382 and lutikizumab. When participants join the study, they will be randomized into available study treatment groups. Adult participants with CD will be enrolled. Around 500 participants will be enrolled in the study at approximately 300 sites worldwide.
Risankizumab and ABBV-382 are given as an injection under the skin or as an infusion into the vein. Lutikizumab is given as an injection under the skin. Each group includes a 12-week induction period, a 12-week maintenance period, and an optional long-term extension period where medication will be given after the maintenance period.
There may be higher treatment burden for participants in this trial compared to their standard of care treatment without participating in this study. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, endoscopies, checking for side effects and completing questionnaires and a daily diary.

Start Date04 Sep 2024

Sponsor / Collaborator

AbbVie, Inc.

NCT06524635 / RecruitingPhase 2

A Multicenter Open-Label Interventional Biomarker Study of Lutikizumab in Adult Subjects With Moderate-to-Severe Hidradenitis Suppurativa or Adult Subjects With Moderate-to-Severe Atopic Dermatitis

Hidradenitis suppurativa (HS) and atopic dermatitis (AD) are chronic inflammatory skin diseases that lead to the development of skin lesions and symptoms such as pain and discomfort. The purpose of this study is to assess molecular changes in adult participants with moderate to severe HS or with moderate to severe AD.
Lutikizumab (ABT-981) is an investigational drug being developed for the treatment of HS and AD. This study will consist of 2 sub-studies: Sub-Study 1 moderate to severe hidradenitis suppurativa and Sub-Study 2 moderate to severe atopic dermatitis. Approximate 60 participants will be enrolled in the study at approximately 2 sites in the US.
In Sub-Study 1 HS participants will receive subcutaneous (SC) injections of lutikizumab for up to week 15 with a 70-day follow-up period. In Sub-Study 2 AD, participants will receive subcutaneous (SC) injections of lutikizumab for up to week 14 with a 70-day follow-up period. The study duration for Sub-Studies 1 and 2 is expected to last up to 30 weeks.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and biomarker collections.

Start Date14 Aug 2024

Sponsor / Collaborator

AbbVie, Inc.

NCT06468228 / RecruitingPhase 3

A Phase 3 Multicenter, Randomized, Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lutikizumab in Adult and Adolescent Subjects With Moderate to Severe Hidradenitis Suppurativa

Hidradenitis suppurativa (HS) is a chronic and often painful inflammatory skin disease which includes the forming of lumps, abscesses and scars in areas of the skin such as under the breasts, under armpits, inner thighs, groin and buttocks. This study will compare lutikizumab versus placebo for the treatment of adult and adolescent participants with moderate to severe HS .
Lutikizumab is an investigational drug being developed for the treatment of HS. During Period 1 of the study, participants will placed in 1 of 2 groups called treatment arms. There is a 1 in 2 chance that participants will be assigned to placebo. Around 1280 adult and adolescent participants with moderate to severe HS will be enrolled in the study at approximately 275 sites world wide. During Period 2, participants that were part of the lutikizumab treatment arm in Period 1 will be re-randomized to 1 of 2 lutikizumab treatment arms. Participants that were part of the Placebo arm in Period 1 will start Period 2 with an initiation of lutikizumab followed by a re-randomization to 1 of 2 lutikizumab treatment arms.
In Period 1, participants will receive subcutaneous injections of lutikizumab or placebo every week for 16 weeks. In Period 2, participants that were randomized to lutikizumab in Period 1 will receive subcutaneous injections of lutikizumab every week or every other week for 36-weeks. Participants that were randomized to the placebo arm in Period 1 will receive subcutaneous injections of lutikizumab every week for 16 weeks, then either every week or every other week for 20 weeks
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires and diaries.

Start Date27 Jun 2024

Sponsor / Collaborator

AbbVie, Inc.

100 Clinical Results associated with Lutikizumab

100 Translational Medicine associated with Lutikizumab

100 Patents (Medical) associated with Lutikizumab

Literatures (Medical) associated with Lutikizumab

01 Mar 2024·Osteoarthritis and cartilage open

Does sex affect the efficacy of systemic pharmacological treatments of pain in knee osteoarthritis? A systematic review

Review

Author: Schnitzer, Thomas J ; Bagherzadeh, Leila ; Wafford, Q Eileen ; Espinosa-Salas, Santiago ; Witte, Graeme

Objective:

To determine whether sex influences the analgesic efficacy of systemic pharmacological treatment in patients with knee osteoarthritis.

Design:

A systematic review, guided by Cochrane methods, sourced studies from Medline, Cochrane Library, Embase, and CINAHL Plus with Full Text as of October 10, 2022. Eligible studies were double-blind RCTs evaluating systemic pharmacological treatments for knee osteoarthritis in adults, with minimum 30-day treatment duration, reporting sex-specific results or mentioning sex subgroup analysis for analgesic efficacy. The risk of bias was assessed using the Cochrane Risk of Bias tool version 2 (RoB 2).

Results:

9 studies (5201 participants) met inclusion criteria, analyzing drugs including duloxetine, etoricoxib, tapentadol, naproxcinod, lutikizumab, and rofecoxib. Only one study reported sex-specific results. Review findings suggested no significant sex-based differences in treatment efficacy, however, data were limited due to a lack of sex-specific reporting or inclusion of sex in subgroup analyses.

Conclusions:

Current evidence does not support the existence of sex differences in the analgesic efficacy of systemic knee osteoarthritis treatments. However, this conclusion is substantially limited by the paucity of sex-specific reporting of results or subgroup analyses in most primary studies, emphasizing the need for future research to report on sex-stratified data to allow for comprehensive, personalized treatment strategies.

04 Nov 2020·BioMed research internationalQ3 · BIOLOGY

Is Lutikizumab, an Anti–Interleukin-1α/β Dual Variable Domain Immunoglobulin, efficacious for Osteoarthritis? Results from a bayesian network meta-analysis

Q3 · BIOLOGY

ArticleOA

Author: Zhou, Jian ; Wu, Ren ; Aili, Dilihumaer ; Dou, Pengcheng ; Li, Yihan ; Jie, Shuo ; Cao, Ziqin ; Hu, Xuantao ; Li, Yajia ; Long, Zeling ; Wu, Tong ; Wang, Wanchun

Objective. Most guidelines recommend the use of nonsteroidal anti-inflammatory drugs (NSAIDs), duloxetine, and tramadol for the nonoperative treatment of osteoarthritis (OA), but the use of them is limited by the tolerability and safety concerns. Lutikizumab is a novel anti–IL-1α/β dual variable domain immunoglobulin that can simultaneously bind and inhibit IL-1α and IL-1β to relieve the pain and dysfunction symptoms. We conducted this network meta-analysis to comprehensively compare the clinical efficacy and safety of lutikizumab with other drugs recommended by guidelines. Methods. We conducted a Bayesian network and conventional meta-analyses to compare the efficacy and safety of lutikizumab with other traditional drugs. All eligible randomized clinical trials, in PubMed, CNKI, EMBASE, and Web of Science databases, from January 2000 to January 2020, were included. The Cochrane risk of the bias assessment tool was used for quality assessment. Pain relief, function improvement, and risk of adverse effects (AEs) were compared in this study. Results. 24 articles with 11858 patients were included. Duloxetine (DUL) had the largest effect for pain relief (4.76, 95% CI [2.35 to 7.17]), and selective cox-2 inhibitors (SCI) were the most efficacious treatment for physical function improvement (SMD 3.94, 95% CI [2.48 to 5.40]). Lutikizumab showed no benefit compared with placebo for both pain relief (SMD 1.11, 95% CI [-2.29 to 4.52]) and function improvement (SMD 0.992, 95% CI [-0.433 to 4.25]). Lutikizumab and all other drugs are of favorable tolerance for patients in the treatment of OA compared with placebo. Conclusions. Lutikizumab, the new anti–Interleukin-1α/β dual variable domain immunoglobulin, showed no improvement in pain or function when compared with placebo. Selective cox-2 inhibitors and duloxetine remain the most effective and safest treatment for OA. More high-quality trials are still needed to reconfirm the findings of this study.

01 Jul 2020·Annals of the rheumatic diseases

Can IL-1 be used as a target for osteoarthritis?

Letter

Author: Tian, Jian ; Zhang, Fangjie ; Cheng, Chao

We read with deep interest the article by Kloppenburg et al ,1 which was aimed at assessing the efficacy, safety, pharmacokinetics and pharmacodynamics of anti-interleukin (IL)-1α/β dual variable domain immunoglobulin lutikizumab (ABT-981) in erosive hand osteoarthritis (HOA). The results indicated that administration of 200 mg lutikizumab subcutaneously every 2 weeks for 24 weeks did not improve pain or imaging outcomes in erosive HOA compared with a placebo. This conclusion might be disappointing for doctors and even patients who desire a wider choice in drugs. In this study, the authors administered lutikizumab to neutralise the expression of IL-1α and IL-1β; however, to the best of our knowledge, until recently, the source …

News (Medical) associated with Lutikizumab

30 Oct 2024

·www.prnewswire.com

AbbVie Reports Third-Quarter 2024 Financial Results

Reports Third-Quarter Diluted EPS of $0.88 on a GAAP Basis, a Decrease of 12.0 Percent; Adjusted Diluted EPS of $3.00, an Increase of 1.7 Percent; These Results Include an Unfavorable Impact of $0.04 Per Share Related to Acquired IPR&D and Milestones Expense Delivers Third-Quarter Net Revenues of $14.460 Billion, an Increase of 3.8 Percent on a Reported Basis or 4.9 Percent on an Operational Basis Third-Quarter Global Net Revenues from the Immunology Portfolio Were $7.046 Billion, an Increase of 3.9 Percent on a Reported Basis, or 4.8 Percent on an Operational Basis; Global Humira Net Revenues Were $2.227 Billion; Global Skyrizi Net Revenues Were $3.205 Billion; Global Rinvoq Net Revenues Were $1.614 Billion Third-Quarter Global Net Revenues from the Oncology Portfolio Were $1.687 Billion, an Increase of 11.6 Percent on a Reported Basis, or 13.0 Percent on an Operational Basis; Global Imbruvica Net Revenues Were $828 Million; Global Venclexta Net Revenues Were $677 Million Third-Quarter Global Net Revenues from the Neuroscience Portfolio Were $2.363 Billion, an Increase of 15.6 Percent on a Reported Basis, or 16.0 Percent on an Operational Basis; Global Botox Therapeutic Net Revenues Were $848 Million; Global Vraylar Net Revenues Were $875 Million; Combined Global Ubrelvy and Qulipta Net Revenues Were $445 Million Third-Quarter Global Net Revenues from the Aesthetics Portfolio Were $1.239 Billion, a Decrease of 0.1 Percent on a Reported Basis, or an Increase of 1.8 Percent on an Operational Basis; Global Botox Cosmetic Net Revenues Were $671 Million; Global Juvederm Net Revenues Were $258 Million Successfully Completed Acquisition of Cerevel, Adding Pipeline of Highly Complementary Assets to AbbVie's Existing Neuroscience Portfolio Raises 2024 Adjusted Diluted EPS Guidance Range from $10.67 - $10.87 to $10.90 - $10.94, which Includes an Unfavorable Impact of $0.64 Per Share Related to Acquired IPR&D and Milestones Expense Incurred Year-To-Date Through the Third Quarter 2024 Announces 2025 Dividend Increase of 5.8 Percent, Beginning with Dividend Payable in February 2025 NORTH CHICAGO, Ill., Oct. 30, 2024 /PRNewswire/ -- AbbVie (NYSE:ABBV) announced financial results for the third quarter ended September 30, 2024. "We delivered another quarter of strong commercial execution and significant pipeline progress," said Robert A. Michael, chief executive officer, AbbVie. "Based upon the momentum of AbbVie's business and our confidence in the long-term growth outlook, we are once again raising our full-year guidance and are increasing our quarterly dividend." Third -Quarter Results Worldwide net revenues were $14.460 billion, an increase of 3.8 percent on a reported basis, or 4.9 percent on an operational basis. Global net revenues from the immunology portfolio were $7.046 billion, an increase of 3.9 percent on a reported basis, or 4.8 percent on an operational basis. Global Humira net revenues of $2.227 billion decreased 37.2 percent on a reported basis, or 36.5 percent on an operational basis. U.S. Humira net revenues were $1.765 billion, a decrease of 41.6 percent. Internationally, Humira net revenues were $462 million, a decrease of 12.4 percent on a reported basis, or 7.8 percent on an operational basis. Global Skyrizi net revenues were $3.205 billion, an increase of 50.8 percent on a reported basis, or 51.5 percent on an operational basis. Global Rinvoq net revenues were $1.614 billion, an increase of 45.3 percent on a reported basis, or 47.4 percent on an operational basis. Global net revenues from the oncology portfolio were $1.687 billion, an increase of 11.6 percent on a reported basis, or 13.0 percent on an operational basis. Global Imbruvica net revenues were $828 million, a decrease of 8.8 percent, with U.S. net revenues of $618 million and international profit sharing of $210 million. Global Venclexta net revenues were $677 million, an increase of 14.8 percent on a reported basis, or 18.2 percent on an operational basis. Global Elahere net revenues were $139 million. Global net revenues from the neuroscience portfolio were $2.363 billion, an increase of 15.6 percent on a reported basis, or 16.0 percent on an operational basis. Global Botox Therapeutic net revenues were $848 million, an increase of 13.4 percent on a reported basis, or 14.4 percent on an operational basis. Global Vraylar net revenues were $875 million, an increase of 16.6 percent. Global Ubrelvy net revenues were $269 million, an increase of 15.3 percent. Global Qulipta net revenues were $176 million, an increase of 33.6 percent. Global net revenues from the aesthetics portfolio were $1.239 billion, a decrease of 0.1 percent on a reported basis, or an increase of 1.8 percent on an operational basis. Global Botox Cosmetic net revenues were $671 million, an increase of 8.2 percent on a reported basis, or 9.9 percent on an operational basis. Global Juvederm net revenues were $258 million, a decrease of 19.7 percent on a reported basis, or 16.9 percent on an operational basis. On a GAAP basis, the gross margin ratio in the third quarter was 70.9 percent. The adjusted gross margin ratio was 84.4 percent. On a GAAP basis, selling, general and administrative (SG&A) expense was 29.1 percent of net revenues. The adjusted SG&A expense was 23.0 percent of net revenues. On a GAAP basis, research and development (R&D) expense was 14.7 percent of net revenues. The adjusted R&D expense was 14.2 percent of net revenues. Acquired IPR&D and milestones expense was 0.6 percent of net revenues. On a GAAP basis, the operating margin in the third quarter was 26.5 percent. The adjusted operating margin was 46.7 percent. Net interest expense was $591 million. On a GAAP basis, the tax rate in the quarter was 25.0 percent. The adjusted tax rate was 16.2 percent. Diluted EPS in the third quarter was $0.88 on a GAAP basis. Adjusted diluted EPS, excluding specified items, was $3.00. These results include an unfavorable impact of $0.04 per share related to acquired IPR&D and milestones expense. Note: "Operational" comparisons are presented at constant currency rates that reflect comparative local currency net revenues at the prior year's foreign exchange rates. Recent Events AbbVie announced that it completed its acquisition of Cerevel, adding a pipeline of highly complementary assets to AbbVie's existing neuroscience portfolio. Cerevel's pipeline includes emraclidine, a potential best-in-class, next-generation antipsychotic, that is being studied for the treatment of schizophrenia; tavapadon, a first-in-class dopamine D1/D5 selective partial agonist for the management of Parkinson's disease (PD); as well as CVL-354, a potential best-in-class kappa opioid receptor (KOR) antagonist being studied for the treatment of major depressive disorder (MDD). Cerevel is a strong strategic fit for AbbVie and has potential to meaningfully impact revenue into the next decade. AbbVie announced positive topline results from its pivotal Phase 3 TEMPO-1 trial evaluating tavapadon as a fixed-dose monotherapy treatment in early PD. In the study, tavapadon met the primary endpoint, demonstrating a statistically significant improvement from baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II and III combined score at week 26. Tavapadon also met the key secondary endpoint, demonstrating statistically significant improvement from baseline in the MDS-UPDRS Part II score. Full results from the TEMPO-1 study will be submitted for presentation at future medical meetings and used to support regulatory submissions of tavapadon as a treatment for PD. Topline results from TEMPO-2, the Phase 3 flexible-dose monotherapy trial for tavapadon, are expected by the end of 2024. AbbVie announced the U.S. Food and Drug Administration (FDA) approved Vyalev (foscarbidopa and foslevodopa) as the first subcutaneous 24-hour infusion of levodopa-based therapy for the treatment of motor fluctuations in adults with advanced PD. The approval was supported by results from a pivotal Phase 3 head-to-head, randomized and controlled clinical trial that demonstrated a statistically significant improvement in "on" time without troublesome dyskinesia and decreased "off" time, compared to oral immediate-release carbidopa/levodopa (CD/LD). AbbVie and Aliada Therapeutics announced a definitive agreement under which AbbVie will acquire Aliada, a biotechnology company advancing therapies using a novel blood-brain barrier (BBB)-crossing technology to address challenging central nervous system (CNS) diseases. Aliada's lead investigational asset utilizing this delivery technology, ALIA-1758, is an anti-pyroglutamate amyloid beta (3pE-Aβ) antibody in development for the treatment of Alzheimer's disease (AD). The acquisition also allows AbbVie to utilize Aliada's novel BBB-crossing technology to enhance discovery and development efforts across neuroscience. AbbVie and Gedeon Richter announced a new discovery, co-development and license agreement to advance novel targets for the potential treatment of neuropsychiatric conditions. This collaboration expands upon the success of nearly two decades of partnership on CNS projects. AbbVie announced the European Commission (EC) approved Skyrizi (risankizumab) for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to conventional or biologic therapy. The approval was supported by data from two pivotal Phase 3 trials in which Skyrizi achieved the primary endpoint of clinical remission as well as key secondary endpoints. This marketing authorization for Skyrizi marks its fourth approved indication in the European Union (EU). Skyrizi is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally. At the European Academy of Dermatology and Venerology (EADV) Congress 2024, AbbVie shared more than 30 presentations that showcased the depth and strength of AbbVie's dermatology portfolio. Presentations highlighted data for Rinvoq (upadacitinib), Skyrizi and lutikizumab across a multitude of dermatological conditions. AbbVie announced that the EC granted conditional marketing authorization for Tepkinly (epcoritamab) as a monotherapy for the treatment of adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of prior therapy. Tepkinly is the first subcutaneous bispecific antibody conditionally approved as a monotherapy in the EU to treat both r/r FL and r/r diffuse large B-cell lymphoma (DLBCL), after two or more lines of prior therapy. The EC approval is supported by data from the Phase 1/2 EPCORE NHL-1 clinical trial, which evaluated the safety and efficacy of Tepkinly in adult patients with r/r FL. Tepkinly is being co-developed by AbbVie and Genmab. AbbVie announced the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the marketing authorization of Elahere (mirvetuximab soravtansine) for the treatment of adult patients with folate receptor alpha (FRα)-positive, platinum-resistant and high-grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer who have received one to three prior treatment regimens. The CHMP's opinion is supported by results of the Phase 3 MIRASOL clinical trial and the EC decision on this indication for Elahere is anticipated later this year. AbbVie announced submission of a Biologics License Application (BLA) to the FDA for accelerated approval (AA) of Teliso-V (telisotuzumab vedotin) in adult patients with previously treated, locally advanced or metastatic epidermal growth factor receptor (EGFR) wild type, nonsquamous non-small cell lung cancer (NSCLC) with c-Met protein overexpression. The BLA is supported by data from the Phase 2 LUMINOSITY clinical trial and review of the BLA will be conducted under FDA's Oncology Center of Excellence (OCE) Real-Time Oncology Review (RTOR) program. There are currently no approved anti-cancer therapies specifically for c-Met overexpressing NSCLC and if approved, Teliso-V would be the first-in-class therapy for this patient population. At the European Society for Medical Oncology (ESMO) Congress 2024, AbbVie showcased new data from its innovative antibody-drug conjugate (ADC) platform in tumor types with high unmet needs. Highlights included full data from the primary analysis of the positive, single-arm Phase 2 PICCOLO trial, evaluating Elahere for high FRα expressing platinum-sensitive ovarian cancer (PSOC); patient reported outcomes from the Phase 2 LUMINOSITY trial, evaluating Teliso-V in advanced NSCLC; as well as new safety and efficacy data in pre-treated patients with advanced NSCLC and gastroesophageal (GEA) cancer, from a Phase 1 study of ABBV-400 (telisotuzumab adizutecan). Allergan Aesthetics announced the FDA approved Botox Cosmetic (onabotulinumtoxinA) for temporary improvement in the appearance of moderate to severe vertical bands connecting the jaw and neck (platysma bands) in adults. Botox Cosmetic is the first product with four aesthetic indication areas: forehead lines, frown lines, crow's feet lines, and now platysma bands, making it the first product of its kind to go beyond the face. Allergan Aesthetics announced the launch of Botox Cosmetic for the treatment of masseter muscle prominence (MMP) in China. The approval is supported by Botox Cosmetic's well-established safety profile as well as clinical trial data that demonstrated Botox Cosmetic is effective in reducing the prominence of the masseter muscle. Botox Cosmetic is the first neurotoxin approved in China for MMP, the largest global MMP market. Allergan Aesthetics intends to develop Botox Cosmetic treatment for MMP in additional global markets and expand the use of Botox Cosmetic in the lower face. At the American Society for Dermal Surgery (ASDS), Allergan Aesthetics presented a total of 12 abstracts that showcased its commitment to patient outcomes and detailed insights and understanding of key concerns across differentiated patient segments. Highlights included four Best of Cosmetic Abstracts as well as a panel discussion on the impact of social media on patient experience and expectations when considering aesthetic treatment. Full-Year 2024 Outlook AbbVie is raising its adjusted diluted EPS guidance for the full year 2024 from $10.67 - $10.87 to $10.90 - $10.94, which includes an unfavorable impact of $0.64 per share related to acquired IPR&D and milestones expense incurred year-to-date through the third quarter 2024. The company's 2024 adjusted diluted EPS guidance excludes any impact from acquired IPR&D and milestones that may be incurred beyond the third quarter of 2024, as both cannot be reliably forecasted. Any potential IPR&D and milestones expense related to the recently announced acquisition of Aliada Therapeutics is also excluded from AbbVie's 2024 adjusted diluted EPS guidance, as the transaction is expected to close in the fourth quarter of 2024. Company Declares Dividend Increase of 5.8 Percent AbbVie is announcing today that its board of directors declared an increase in the company's quarterly cash dividend from $1.55 per share to $1.64 per share beginning with the dividend payable on February 14, 2025 to shareholders of record as of January 15, 2025. This reflects an increase of approximately 5.8 percent, continuing AbbVie's strong commitment to returning cash to shareholders through a growing dividend. Since the company's inception in 2013, AbbVie has increased its quarterly dividend by 310 percent. AbbVie is a member of the S&P Dividend Aristocrats Index, which tracks companies that have annually increased their dividend for at least 25 consecutive years. About AbbVie AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience and eye care - and products and services across our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on X (formerly Twitter), Facebook, Instagram, YouTube or LinkedIn. Conference Call AbbVie will host an investor conference call today at 8:00 a.m. Central Time to discuss our third-quarter performance. The call will be webcast through AbbVie's Investor Relations website at investors.abbvie.com. An archived edition of the call will be available after 11:00 a.m. Central Time. Non-GAAP Financial Results Financial results for 2024 and 2023 are presented on both a reported and a non-GAAP basis. Reported results were prepared in accordance with GAAP and include all revenue and expenses recognized during the period. Non-GAAP results adjust for certain non-cash items and for factors that are unusual or unpredictable, and exclude those costs, expenses, and other specified items presented in the reconciliation tables later in this release. AbbVie's management believes non-GAAP financial measures provide useful information to investors regarding AbbVie's results of operations and assist management, analysts, and investors in evaluating the performance of the business. Non-GAAP financial measures should be considered in addition to, and not as a substitute for, measures of financial performance prepared in accordance with GAAP. Forward-Looking Statements Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2023 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. SOURCE AbbVie WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultDrug ApprovalPhase 3License out/inAcquisition

29 Mar 2024

·www.biospace.com

Avalo Snags Former Eli Lilly Asset and $185M in Major Pipeline Pivot

Pictured: Close-up of a skin lesion in a patient with hidradenitis suppurativa/iStock, krblokhin Avalo Therapeutics made a significant strategic pipeline decision Wednesday, acquiring AlmataBio and focusing on the biotech’s ex-Eli Lilly hidradenitis suppurativa candidate over its existing assets. Prior to the deal, Avalo was advancing a pipeline led by an inflammatory bowel disease drug candidate. Quisovalimab, an anti-LIGHT antibody, and an BTLA agonist fusion protein remain part of Avalo’s pipeline but are now listed as “under strategic review.” The focus is on getting the acquired anti-IL-1β antibody AVTX-009 to a Phase II readout in the chronic skin condition hidradenitis suppurativa (HS). Investors have stepped up to bankroll Avalo’s goal of reporting topline results in the indication in 2026. Commodore Capital and TCGX co-led a private placement in the biotech with assists from BVF Partners, Deep Track Capital, OrbiMed, Petrichor and RA Capital Management. The placement is worth up to $185 million, $115.6 million of which the investors are providing upfront. “We believe that HS is a multi-billion-dollar commercial opportunity and that AVTX-009 has the potential to be best-in-class and best-in-indication because of its target, half-life and potency, which may allow for strong efficacy and convenient dosing,” Avalo CEO Garry Neil said in a statement. Avalo expects the upfront money to fund its operations into 2027. As such, the money will enable the biotech to show how AVTX-009 performs in HS in a Phase II trial. Avalo contends the molecule has a high probability of success in the indication. That belief is based on data generated by other developers of IL-1β drug candidates. AbbVie is running a Phase II clinical trial of the anti-IL-1α/β antibody lutikizumab in patients with HS. The drugmaker published data from the study and committed to further development early in 2024. While AbbVie’s success partly derisks AVTX-009, it also means Avalo is up against a leading drugmaker that has advanced deeper into the clinic. Avalo’s asset is different from lutikizumab in that it only targets IL-1β. As Avalo has said, clinical evidence suggests anti-IL-1α therapy is not effective in HS. The evidence comes from a Johnson & Johnson candidate that failed a Phase II clinical trial. Eli Lilly originally developed AVTX-009 but then offloaded the asset to AlmataBio. Avalo is taking control of the molecule by paying AlmataBio shareholders $15 million in stock and $7.5 million in cash. The deal also includes a $5 million milestone payment tied to the dosing of the first patient in Phase II. Avalo will pay a further $15 million when it doses the first patient in a Phase III trial. Nick Paul Taylor is a freelance pharmaceutical and biotech writer based in London. He can be reached on LinkedIn.

Phase 2AcquisitionPhase 1Phase 3Clinical Trial Failure

06 Mar 2024

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AbbVie and Allergan Aesthetics to Present New Data at 2024 Annual AAD Meeting Showcasing Depth and Strength Across Dermatology and Aesthetics Portfolios

A total of 29 abstracts, including three late-breaking presentations, demonstrate AbbVie and Allergan Aesthetics' shared commitment to advancing science across a spectrum of immune-mediated dermatologic conditions and aesthetic indications NORTH CHICAGO, Ill., March 6, 2024 /PRNewswire/ --AbbVie (NYSE: ABBV) and Allergan Aesthetics, an AbbVie company, today announced they will present 29 abstracts, including three late-breaking presentations, during the 2024 American Academy of Dermatology (AAD) Annual Meeting, March 8-12, in San Diego, California. The presented data across AbbVie and Allergan Aesthetics' extensive portfolios reinforce the companies' ongoing commitment to developing transformative medical dermatology and aesthetic treatments to advance and redefine the standard of care for patients. The oral and poster presentations from AbbVie highlight efficacy, durability and safety data across the company's dermatology portfolio. Notable presentations include: Efficacy data of RINVOQ® (upadacitinib) on nighttime itch and sleep disturbance, and minimal disease activity in patients with moderate-to-severe atopic dermatitis Data evaluating the efficacy of SKYRIZI® (risankizumab-rzaa) on difficult to treat areas including for the treatment of scalp and nail psoriasis compared to apremilast in adults with moderate psoriasis, and safety and efficacy of SKYRIZI® (risankizumab-rzaa) in adults with moderate to severe plaque psoriasis with palmoplantar (nonpustular) involvement Data evaluating changes in tissue-resident memory T cell (Trm) populations after high-induction dosing of SKYRIZI® (risankizumab-rzaa) in patients with moderate-to-severe plaque psoriasis AbbVie is also presenting data across a number of underserved dermatologic diseases across new and existing molecules. Key research includes: Phase 2 efficacy and safety data for lutikizumab (ABT-981), which has a novel mechanism of action, in the treatment of moderate to severe hidradenitis suppurativa being presented for the first time at a medical meeting Efficacy and safety results of a Phase 2, 52-week study for upadacitinib in the treatment of non-segmental vitiligo New data on disease and economic burden of alopecia areata in the United States "AbbVie's commitment to advancing standards of care in dermatology is underscored by the breadth of new research presented at AAD this year," said Andrew Anisfeld, Ph.D., vice president, global medical affairs, Immunology, AbbVie. "We are dedicated to improving patient outcomes and helping to redefine treatment expectations so that all patients may feel free in their own skin." With a growing pipeline of more than 60 programs in development, Allergan Aesthetics has one of the most robust portfolios for aesthetics innovation in the industry. At AAD the company will spotlight: Detailed results from two Phase 3 studies of onabotulinumtoxinA (BOTOX® Cosmetic) for the treatment of platysma prominence, an aesthetically unappealing disruption to the lines and contour of the lower face and neck that can occur as part of the natural aging process. Topline results shared in 2023 demonstrated all primary and secondary endpoints were met for both studies,1 and if approved, onabotulinumtoxinA will be the first and only neurotoxin for this indication. Data on the safety and effectiveness of JUVÉDERM® VOLUMA® XC for injection in the temple region to improve moderate to severe temple hollowing in adults over the age of 21.2 JUVÉDERM® VOLUMA® XC is the first and only hyaluronic acid (HA) dermal filler to receive U.S. FDA approval for the improvement of moderate to severe temple hollowing with results lasting up to thirteen months with optimal treatment.2 Data on a novel cosmetic regimen for mild to moderate facial acne. "Allergan Aesthetics is focused on creating evidence-based products and technologies that advance aesthetics medicine and address the evolving needs of patients and providers globally," said John Maltman, Ph.D., vice president, global aesthetics medical affairs, Allergan Aesthetics. "With patient safety and optimal outcomes as our main priorities, we are proud to share our learnings and engage with the larger medical community at AAD." Select AbbVie and Allergan Aesthetics abstracts at AAD 2024 are outlined below. The 2024 AAD Annual Meeting e-Posters are available here and late-breaking sessions are available here. SKYRIZI is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization of SKYRIZI globally. About RINVOQ® (upadacitinib) Discovered and developed by AbbVie scientists, RINVOQ is a JAK inhibitor that is being studied in several immune-mediated inflammatory diseases. Based on enzymatic and cellular assays, RINVOQ demonstrated greater inhibitory potency for JAK-1 vs JAK-2, JAK-3, and TYK-2.3 The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness and safety is not currently known. Phase 3 trials of RINVOQ alopecia areata, ankylosing spondylitis, atopic dermatitis, axial spondyloarthritis, Crohn's disease, giant cell arteritis, hidradenitis suppurativa, psoriatic arthritis, rheumatoid arthritis, systemic lupus erythematosus (SLE), Takayasu arteritis, ulcerative colitis and vitiligo are ongoing.4-17 Use of upadacitinib in vitiligo is not approved and its safety and efficacy have not been evaluated by regulatory authorities. RINVOQ (upadacitinib) U.S. Uses and Important Safety Information3 RINVOQ is a prescription medicine used to treat: Adults with moderate to severe rheumatoid arthritis (RA) when 1 or more medicines called tumor necrosis factor (TNF) blockers have been used, and did not work well or could not be tolerated. Adults with active psoriatic arthritis (PsA) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated. Adults with active ankylosing spondylitis (AS) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated. Adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation when a TNF blocker medicine has been used, and did not work well or could not be tolerated. Adults with moderate to severe ulcerative colitis (UC) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated. Adults with moderate to severe Crohn's disease (CD) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated. It is not known if RINVOQ is safe and effective in children with juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, ulcerative colitis, or Crohn's disease. Adults and children 12 years of age and older with moderate to severe eczema (atopic dermatitis [AD]) that did not respond to previous treatment and their eczema is not well controlled with other pills or injections, including biologic medicines, or the use of other pills or injections is not recommended. RINVOQ is safe and effective in children 12 years of age and older weighing at least 88 pounds (40 kg) with atopic dermatitis. It is not known if RINVOQ is safe and effective in children under 12 years of age with atopic dermatitis. What is the most important information I should know about RINVOQ? RINVOQ may cause serious side effects, including: Serious infections. RINVOQ can lower your ability to fight infections. Serious infections have happened while taking RINVOQ, including tuberculosis (TB) and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Your healthcare provider (HCP) should test you for TB before starting RINVOQ and check you closely for signs and symptoms of TB during treatment with RINVOQ. You should not start taking RINVOQ if you have any kind of infection unless your HCP tells you it is okay. If you get a serious infection, your HCP may stop your treatment until your infection is controlled. You may be at higher risk of developing shingles (herpes zoster). Increased risk of death in people 50 years and older who have at least 1 heart disease (cardiovascular) risk factor. Cancer and immune system problems. RINVOQ may increase your risk of certain cancers. Lymphoma and other cancers, including skin cancers, can happen. Current or past smokers are at higher risk of certain cancers, including lymphoma and lung cancer. Follow your HCP's advice about having your skin checked for skin cancer during treatment with RINVOQ. Limit the amount of time you spend in sunlight. Wear protective clothing when you are in the sun and use sunscreen. Increased risk of major cardiovascular (CV) events, such as heart attack, stroke, or death, in people 50 years and older who have at least 1 heart disease (CV) risk factor, especially if you are a current or past smoker. Blood clots: Blood clots in the veins of the legs or lungs and arteries can happen with RINVOQ. This may be life-threatening and cause death. Blood clots in the veins of the legs and lungs have happened more often in people who are 50 years and older and with at least 1 heart disease (CV) risk factor. Allergic reactions. Symptoms such as rash (hives), trouble breathing, feeling faint or dizzy, or swelling of your lips, tongue, or throat, that may mean you are having an allergic reaction have been seen in people taking RINVOQ. Some of these reactions were serious. If any of these symptoms occur during treatment with RINVOQ, stop taking RINVOQ and get emergency medical help right away. Tears in the stomach or intestines. This happens most often in people who take nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids. Get medical help right away if you get stomach-area pain, fever, chills, nausea, or vomiting. Changes in certain laboratory tests. Your HCP should do blood tests before you start taking RINVOQ and while you take it. Your HCP may stop your RINVOQ treatment for a period of time if needed because of changes in these blood test results. Do not take RINVOQ if you are allergic to upadacitinib or any of the ingredients in RINVOQ. See the Medication Guide or Consumer Brief Summary for a complete list of ingredients. What should I tell my HCP BEFORE starting RINVOQ? Tell your HCP if you: Are being treated for an infection, have an infection that won't go away or keeps coming back, or have symptoms of an infection such as: Fever, sweating, or chills Shortness of breath Warm, red, or painful skin or sores on your body Muscle aches Feeling tired Blood in phlegm Diarrhea or stomach pain Cough Weight loss Burning when urinating or urinating more often than normal Have TB or have been in close contact with someone with TB. Are a current or past smoker. Have had a heart attack, other heart problems, or stroke. Have had any type of cancer, hepatitis B or C, shingles (herpes zoster), blood clots in the veins of your legs or lungs, diverticulitis (inflammation in parts of the large intestine), or ulcers in your stomach or intestines. Have other medical conditions including liver problems, low red or white blood cell counts, diabetes, chronic lung disease, HIV, or a weak immune system. Live, have lived, or have traveled to parts of the country, such as the Ohio and Mississippi River valleys and the Southwest, that increase your risk of getting certain kinds of fungal infections. If you are unsure if you've been to these types of areas, ask your HCP. Have recently received or are scheduled to receive a vaccine. People who take RINVOQ should not receive live vaccines. Are pregnant or plan to become pregnant. Based on findings in animal studies, RINVOQ may harm your unborn baby. Your HCP will check whether or not you are pregnant before you start RINVOQ. You should use effective birth control (contraception) to avoid becoming pregnant during treatment with RINVOQ and for 4 weeks after your last dose. There is a pregnancy surveillance program for RINVOQ. The purpose of the program is to collect information about the health of you and your baby. If you become pregnant while taking RINVOQ, you are encouraged to report the pregnancy by calling 1-800-633-9110. Are breastfeeding or plan to breastfeed. RINVOQ may pass into your breast milk. Do not breastfeed during treatment with RINVOQ and for 6 days after your last dose. Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. RINVOQ and other medicines may affect each other, causing side effects. Especially tell your HCP if you take: Medicines for fungal or bacterial infections Rifampicin or phenytoin Medicines that affect your immune system If you are not sure if you are taking any of these medicines, ask your HCP or pharmacist. What should I avoid while taking RINVOQ? Avoid food or drink containing grapefruit during treatment with RINVOQ as it may increase the risk of side effects. What should I do or tell my HCP AFTER starting RINVOQ? Tell your HCP right away if you have any symptoms of an infection. RINVOQ can make you more likely to get infections or make any infections you have worse. Get emergency help right away if you have any symptoms of a heart attack or stroke while taking RINVOQ, including: Discomfort in the center of your chest that lasts for more than a few minutes or that goes away and comes back Severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw Pain or discomfort in your arms, back, neck, jaw, or stomach Shortness of breath with or without chest discomfort Breaking out in a cold sweat Nausea or vomiting Feeling lightheaded Weakness in one part or on one side of your body Slurred speech Tell your HCP right away if you have any signs or symptoms of blood clots during treatment with RINVOQ, including: Swelling Pain or tenderness in one or both legs Sudden unexplained chest or upper back pain Shortness of breath or difficulty breathing Tell your HCP right away if you have a fever or stomach-area pain that does not go away, and a change in your bowel habits. What are other possible side effects of RINVOQ? Common side effects include upper respiratory tract infections (common cold, sinus infections), shingles (herpes zoster), herpes simplex virus infections (including cold sores), bronchitis, nausea, cough, fever, acne, headache, increased blood levels of creatine phosphokinase, allergic reactions, inflammation of hair follicles, stomach-area (abdominal) pain, increased weight, flu, tiredness, lower number of certain types of white blood cells (neutropenia, lymphopenia, leukopenia), muscle pain, flu-like illness, rash, increased blood cholesterol levels, increased liver enzyme levels, pneumonia, low number of red blood cells (anemia), and infection of the stomach and intestine (gastroenteritis). A separation or tear to the lining of the back part of the eye (retinal detachment) has happened in people with atopic dermatitis treated with RINVOQ. Call your HCP right away if you have any sudden changes in your vision during treatment with RINVOQ. Some people taking RINVOQ may see medicine residue (a whole tablet or tablet pieces) in their stool. If this happens, call your healthcare provider. These are not all the possible side effects of RINVOQ. How should I take RINVOQ? RINVOQ is taken once a day with or without food. Do not split, crush, or chew the tablet. Take RINVOQ exactly as your HCP tells you to use it. RINVOQ is available in 15 mg, 30 mg, and 45 mg extended-release tablets. This is the most important information to know about RINVOQ. For more information, talk to your HCP. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/myAbbVieAssist to learn more. Please click here for the Full Prescribing Information and Medication Guide for RINVOQ. Globally, prescribing information varies; refer to the individual country product label for complete information. About SKYRIZI® (risankizumab-rzaa) SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit.18 IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases, including psoriasis.18 Phase 3 trials of SKYRIZI in psoriasis, Crohn's disease, ulcerative colitis and psoriatic arthritis are ongoing.19 - 24 SKYRIZI® (risankizumab-rzaa) U.S. Indications and Important Safety Information25 SKYRIZI is a prescription medicine used to treat adults with: moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or treatment using ultraviolet or UV light (phototherapy). active psoriatic arthritis (PsA). moderate to severe Crohn's disease. IMPORTANT SAFETY INFORMATION What is the most important information I should know about SKYRIZI® (risankizumab-rzaa)? SKYRIZI is a prescription medicine that may cause serious side effects, including: Serious allergic reactions: Stop using SKYRIZI and get emergency medical help right away if you get any of the following symptoms of a serious allergic reaction: fainting, dizziness, feeling lightheaded (low blood pressure) swelling of your face, eyelids, lips, mouth, tongue, or throat trouble breathing or throat tightness chest tightness skin rash, hives itching Infections: SKYRIZI may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with SKYRIZI and may treat you for TB before you begin treatment with SKYRIZI if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with SKYRIZI. Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including: fever, sweats, or chills cough shortness of breath blood in your mucus (phlegm) muscle aches warm, red, or painful skin or sores on your body different from your psoriasis weight loss diarrhea or stomach pain burning when you urinate or urinating more often than normal Do not use SKYRIZI if you are allergic to risankizumab-rzaa or any of the ingredients in SKYRIZI. See the Medication Guide or Consumer Brief Summary for a complete list of ingredients. Before using SKYRIZI, tell your healthcare provider about all of your medical conditions, including if you: have any of the conditions or symptoms listed in the section "What is the most important information I should know about SKYRIZI?" have an infection that does not go away or that keeps coming back. have TB or have been in close contact with someone with TB. have recently received or are scheduled to receive an immunization (vaccine). Medicines that interact with the immune system may increase your risk of getting an infection after receiving live vaccines. You should avoid receiving live vaccines right before, during, or right after treatment with SKYRIZI. Tell your healthcare provider that you are taking SKYRIZI before receiving a vaccine. are pregnant or plan to become pregnant. It is not known if SKYRIZI can harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if SKYRIZI passes into your breast milk. become pregnant while taking SKYRIZI. You are encouraged to enroll in the Pregnancy Registry, which is used to collect information about the health of you and your baby. Talk to your healthcare provider or call 1-877-302-2161 to enroll in this registry. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. What are the possible side effects of SKYRIZI? SKYRIZI may cause serious side effects. See "What is the most important information I should know about SKYRIZI?" Liver problems in Crohn's disease: A person with Crohn's disease who received SKYRIZI through a vein in the arm developed changes in liver blood tests with a rash that led to hospitalization. Your healthcare provider will do blood tests to check your liver before, during, and up to 12 weeks of treatment and may stop treatment with SKYRIZI if you develop liver problems. Tell your healthcare provider right away if you notice any of the following symptoms: unexplained rash, nausea, vomiting, stomach (abdominal) pain, tiredness (fatigue), loss of appetite, yellowing of the skin and eyes (jaundice), and dark urine. The most common side effects of SKYRIZI in people treated for Crohn's disease include: upper respiratory infections, headache, joint pain, stomach (abdominal) pain, injection site reactions, low red blood cells (anemia), fever, back pain, and urinary tract infection. The most common side effects of SKYRIZI in people treated for plaque psoriasis and psoriatic arthritis include: upper respiratory infections, headache, feeling tired, injection site reactions, and fungal skin infections. These are not all the possible side effects of SKYRIZI. Call your doctor for medical advice about side effects. Use SKYRIZI exactly as your healthcare provider tells you to use it. SKYRIZI is available in a 150 mg/mL prefilled syringe and pen, a 600 mg/10 mL vial for intravenous infusion, and a 180 mg/1.2 mL or 360 mg/2.4 mL single-dose prefilled cartridge with on-body injector. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/myAbbVieAssist to learn more. Please click here for Full Prescribing Information and Medication Guide for SKYRIZI. Globally, prescribing information varies; refer to the individual country product label for complete information. About Lutikizumab (ABT-981) Lutikizumab (ABT-981) is a dual-variable-domain interleukin (IL) 1α/1β antagonist being investigated in several immune-mediated diseases, including hidradenitis suppurativa (HS) and ulcerative colitis. Studies have shown IL 1α and 1β are elevated in HS lesions.26 Lutikizumab is an investigational agent and is not approved by regulatory authorities. Safety and efficacy have not been established. BOTOX® Cosmetic (onabotulinumtoxinA) Important Safety Information BOTOX® Cosmetic (onabotulinumtoxinA) is a prescription medicine that is injected into muscles and used to temporarily improve the look of moderate to severe forehead lines, crow's feet, and frown lines between the eyebrows in adults. Talk to your doctor about BOTOX® Cosmetic and whether it's right for you. There are risks with this product—the effects of BOTOX® Cosmetic may spread hours to weeks after injection causing serious symptoms. Alert your doctor right away as difficulty swallowing, speaking, breathing, eye problems or muscle weakness can be a sign of a life-threatening condition. If this happens, do not drive a car, operate machinery, or do other dangerous activities. Patients with these conditions before injection are at the highest risk. Swallowing problems may last for several months. Side effects may include allergic reactions, neck and injection-site pain, fatigue and headache. Allergic reactions can include rash, welts, asthma symptoms, and dizziness. Don't receive BOTOX® Cosmetic if there's a skin infection. Tell your doctor your medical history, muscle or nerve conditions (including ALS/Lou Gehrig's disease, myasthenia gravis, or Lambert-Eaton syndrome), and medications, including botulinum toxins, as these may increase the risk of serious side effects. Please see BOTOX® Cosmetic Full Product Information including Boxed Warning and Medication Guide. Globally, prescribing information varies; refer to the individual country product label for complete information. JUVÉDERM® VOLUMA® XC Important Information INDICATIONS JUVÉDERM® VOLUMA® XC injectable gel is indicated for deep (subcutaneous and/or supraperiosteal) injection for cheek augmentation to correct age-related volume deficit in the mid-face, for augmentation of the chin region to improve the chin profile, and for supraperiosteal injection to augment the temple region to improve temple hollowing in adults over the age of 21. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS: Not for patients with a history of anaphylaxis, presence of multiple severe allergies, or allergies to Gram-positive bacterial proteins or lidocaine in these products. WARNINGS: Do not inject into blood vessels. Introduction of this product into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction. Rare but serious adverse events associated with the intravascular injection of dermal fillers in the face have been reported and include temporary or permanent vision impairment, blindness, cerebral ischemia or cerebral hemorrhage leading to stroke, skin necrosis, and damage to underlying facial structures. Treatment should be deferred where there is active infection or inflammatory process at the injection site. PRECAUTIONS: This product should only be used by healthcare professionals who are knowledgeable about the anatomy and the product for use in indicated areas, and who have appropriate training in facial anatomy, vasculature, safe injection techniques, and identification and management of potential adverse events, including intravascular complications. The safety for use during pregnancy, breastfeeding, and in patients with known susceptibility to keloid formation, hypertrophic scarring, and pigmentation disorders has not been established. Dermal filler implantation carries a risk of infection. Use in patients who are taking products that prolong bleeding may increase bruising/bleeding at the injection site. Use with caution in patients on immunosuppressive therapy. Patients may experience late-onset adverse events with injectable gel implants. ADVERSE EVENTS: The most common reported side effects were redness, swelling, pain, tenderness, firmness, lumps/bumps, bruising, discoloration, and itching. The majority were mild or moderate in severity. To report an adverse reaction, please call Allergan® Product Support at 1-877-345-5372. Please visit rxabbvie.com for more information. The products in the JUVÉDERM® Collection are available only by a licensed physician or properly licensed practitioner. SkinMedica® Most SkinMedica® products are intended to meet the FDA's definition of a cosmetic product, an article applied to the human body to cleanse, beautify, promote attractiveness, and alter appearances. These SkinMedica® products are not intended to be drug products that diagnose, treat, cure, or prevent any disease or condition. These products have not been approved by the FDA and the statements have not been evaluated by the FDA. About AbbVie AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – in addition to products and services across our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter), and YouTube. About Allergan Aesthetics At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to consistently provide our customers with innovation, education, exceptional service, and a commitment to excellence, all with a personal touch. For more information, visit . Forward-Looking Statements Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2023 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. References AbbVie. (2023, September 18). Allergan Aesthetics Announces Positive Topline Results from Second Phase 3 Study of OnabotulinumtoxinA (BOTOX® Cosmetic) for the Treatment of Platysma Prominence [Press release]. JUVÉDERM® VOLUMA® XC Patient Labeling for Temple. 2024. RINVOQ [Package Insert]. North Chicago, IL: AbbVie Inc.; 2023. A Study to Evaluate Efficacy and Safety of Upadacitinib in Adult Participants With Axial Spondyloarthritis (SELECT AXIS 2). ClinicalTrials.gov. Available at: . Accessed March 24, 2023. A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Adults with Rheumatoid Arthritis Who Are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE). ClinicalTrials.gov. Available at: . Accessed March 24, 2023. A Study to Evaluate the Safety and Efficacy of ABT-494 for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis. ClinicalTrials.gov. Available at: . Accessed March 24, 2023. A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Immunomodulators or Anti-TNF Therapy. ClinicalTrials.gov. Available at: . Accessed March 24, 2023. A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Participants With Psoriatic Arthritis Who Have an Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug (SELECT - PsA 1). ClinicalTrials.gov. Available at: . Accessed March 24, 2023. Evaluation of Upadacitinib in Adolescent and Adult Patients With Moderate to Severe Atopic Dermatitis (Eczema) (Measure Up 1). ClinicalTrials.gov. Available at: . Accessed February 22, 2024 A Study to Evaluate Upadacitinib in Adolescents and Adults With Moderate to Severe Atopic Dermatitis (Measure Up 2). ClinicalTrials.gov. Available at: . Accessed February 22, 2024 A Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis (AD Up). ClinicalTrials.gov. Available at: . Accessed February 22, 2024. A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants with Giant Cell Arteritis (SELECT-GCA). ClinicalTrials.gov. Available at: . Accessed March 30, 2023. A Study to Evaluate the Efficacy and Safety of Upadacitinib in Participants with Takaysu Arteritis (TAK) (SELECT-TAK). ClinicalTrials.gov. Available at: . Accessed March 30, 2023. Program to Assess Adverse Events and Change in Disease Activity of Oral Upadacitinib in Adult Participants With Moderate to Severe Systemic Lupus Erythematosus (SELECT-SLE). ClinicalTrials.gov. Available at: . Accessed February 19, 2024. A Study to Assess Change in Disease Activity and Adverse Events of Oral Upadacitinib in Adult and Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-TNF Therapy (Step-Up HS). ClinicalTrials.gov. Available at: . Accessed February 19, 2024 A Study To Assess Adverse Events and Effectiveness of Upadacitinib Oral Tablets in Adult and Adolescent Participants With Vitiligo (Viti-Up). ClinicalTrials.gov. Available at: . Accessed February 19, 2024. A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants With Severe Alopecia Areata (Up-AA). ClinicalTrials.gov. Available at: . Accessed February 19, 2024. Duvallet E., Sererano L., Assier E., et al. Interleukin-23: a key cytokine in inflammatory diseases. Ann Med. 2011. Nov 43(7):503-11. A Study on the long-term efficacy and safety of risankizumab for the treatment of moderate-to-severe plaque psoriasis. ClinicalTrials.gov. 2021. Available at: . Accessed on February 17, 2023. A Study of the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease. ClinicalTrials.gov. 2021. Available at: . Accessed on March 8, 2022. A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis. ClinicalTrials.gov. 2021. Available at: . Accessed on March 8, 2022. A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Ulcerative Colitis. Available at: . Accessed on March 8, 2022. BI 655066/ABBV-066/Risankizumab Compared to Placebo in Patients With Active Psoriatic Arthritis. Available at: . Accessed on March 8, 2022. BI 655066/ABBV-066/Risankizumab Compared to Placebo in Patients With Active Psoriatic Arthritis. Available at: . Accessed on March 8, 2022. SKYRIZI (risankizumab) [Package Insert]. North Chicago, Ill.: AbbVie Inc. VanderZee et al British Journal of Dermatology (2011) 164, p1292–98; Kanni et al (2015) PLoS ONE 10(6): e0130522. Company Codes: NYSE:ABBV

Phase 3Clinical ResultPhase 2Drug Approval

100 Deals associated with Lutikizumab

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Indication	Highest Phase	Country/Location	Organization	Date
Hidradenitis Suppurativa	Phase 3	US	AbbVie, Inc.	27 Jun 2024
Hidradenitis Suppurativa	Phase 3	JP	AbbVie, Inc.	27 Jun 2024
Hidradenitis Suppurativa	Phase 3	AU	AbbVie, Inc.	27 Jun 2024
Hidradenitis Suppurativa	Phase 3	CA	AbbVie, Inc.	27 Jun 2024
Hidradenitis Suppurativa	Phase 3	NZ	AbbVie, Inc.	27 Jun 2024
Hidradenitis Suppurativa	Phase 3	PR	AbbVie, Inc.	27 Jun 2024
Hidradenitis Suppurativa	Phase 3	TW	AbbVie, Inc.	27 Jun 2024
Crohn Disease	Phase 2	US	AbbVie, Inc.	04 Sep 2024
Crohn Disease	Phase 2	CA	AbbVie, Inc.	04 Sep 2024
Dermatitis, Atopic	Phase 2	US	AbbVie, Inc.	14 Aug 2024

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05139602 (Biospace) Manual	Phase 2	Hidradenitis Suppurativa	153	lutikizumab	iffrvgggbq(orirendbwi) = qhmeucrgeh wqsmrokyvq (vlddlvzjas ) View more	Positive	08 Jan 2024
				placebo	vhompubnjs(ftmjhgextw) = uxzrcbxknd qwakldyxvo (basyicmzpl ) View more
NCT02087904 (CTgov)	Phase 2	Osteoarthritis, Knee	350	Placebo	cesvtbofch(kymxuppsgv) = dgcouxgqqt mrumoctriu (jsktxztgcb, oamciczvov - zmgqgzwach) View more	-	28 Aug 2019
NCT01668511 (Pubmed \| Osteoarthritis Cartilage)	Phase 1	Osteoarthritis, Knee	36	ABT-981 0.3 mg/kg	yrjfnytjvn(gwdducxmwj) = jjogdbjlwa rezmqwowci (bwhuwwvlfq ) View more	-	01 Dec 2017
				ABT-981 1 mg/kg	yrjfnytjvn(gwdducxmwj) = reelrkdqun rezmqwowci (bwhuwwvlfq ) View more
NCT02384538 (CTgov)	Phase 2	Osteoarthritis	132	Placebo for ABT-981 (Placebo)	wfyiaucsux(mcddtmlqiv) = ytasxgqqrf rmkcwgeltd (lmyegnbdas, wmhfqilhan - vmtznijnpe) View more	-	13 Jul 2017
				ABT-981 (ABT-981)	wfyiaucsux(mcddtmlqiv) = cmavgtsnbg rmkcwgeltd (lmyegnbdas, yqwmewxomg - fiptbdzefw) View more
EULAR2014	Phase 1	Osteoarthritis	-	ABT-981	copmguugjt(oeckgnicpc) = Measurable ADA titers were detected in 7 subjects on active treatment btpicdhmzl (capxeaaujl ) View more	-	11 Jun 2014
EULAR2014	Not Applicable	Osteoarthritis, Knee hsCRP \| VEGF \| C1M ... View more	36	ABT-981 0.3 mg/kg	dkhvautcwh(pjxdptljlc) = nonsignificant decreasing trend in the 1 and 3 mg/kg groups yrhjhziomf (hfdqutkpun ) View more	Positive	11 Jun 2014
				ABT-981 1 mg/kg

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