Interventional, Randomized, Double-blind, Placebo-controlled Trial Investigating the Safety and Tolerability of Lu AG09222 When Coadministered With Ubrogepant in Participants With Migraine

The main goal of this trial is to learn more about the safety and tolerability of Lu AG09222 when taken together with ubrogepant. This includes looking for any new or worsening medical issues the participants have with the treatment. During the trial, participants with migraine will receive ubrogepant oral tablets and an injection of either Lu AG09222 or a placebo.

Start Date13 Sep 2024

Sponsor / Collaborator

H. Lundbeck A/S

NCT06417775

/ RecruitingPhase 3

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Ubrogepant for the Preventive Treatment of Menstrual Migraine With an Open-Label Extension

A migraine is a moderate to severe headache typically on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. Menstrual migraine (MM) is defined as migraine attacks that occur within the perimenstrual period (PMP) in at least 2 out of 3 menstrual cycles. The PMP is from 2 days before the onset of menstrual bleeding to 2 days after. This study will assess how safe and effective ubrogepant is in treating menstrual migraine. Adverse Events and change in disease activity will be assessed.
Ubrogepant is an investigational drug being developed for short-term prevention of menstrual migraine. Participants will be randomly assigned to one of the 2 groups to receive either ubrogepant or placebo. Around 450 adult female participants with menstrual migraine will be enrolled in approximately 85 sites in the United States and Puerto Rico.
Participants will receive oral ubrogepant tablets once daily for 7 consecutive days starting 3 days prior to estimated onset of menses per cycle for 3 PMPs during double-blind period (16 weeks). Eligible participants may continue to receive oral ubrogepant tablets once daily for 7 consecutive days per cycle starting 3 days prior to estimated onset of menses during open-label extension period (52 weeks).
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will collect data daily in electronic diaries and 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.

Start Date10 Sep 2024

Sponsor / Collaborator

AbbVie, Inc.

NCT06212661

/ Enrolling by invitationNot ApplicableIIT

Migraine Medication Effects on Urinary Symptoms

A prospective observational cohort trial to study the effects of CGRP inhibitors (CGRPi) on lower urinary tract symptoms (LUTS) and bladder/pelvic pain. Candidates for either CGRPi or an alternative therapy for refractory migraines (OnabotulinumtoxinA (BoNTA) extracranial muscle injections) with baseline LUTS will be recruited. The investigators will assess LUTS and pelvic pain using validated symptom and quality-of-life questionnaires, pretreatment and at 3 months post-treatment follow-up, comparing change in symptoms based on treatment received.

Start Date05 Apr 2024

Sponsor / Collaborator

The Cleveland Clinic Foundation

100 Clinical Results associated with Ubrogepant

100 Translational Medicine associated with Ubrogepant

100 Patents (Medical) associated with Ubrogepant

223

Literatures (Medical) associated with Ubrogepant

01 Feb 2025·ADVANCES IN THERAPY

US Real-World Effectiveness, Tolerability, and Healthcare Resource Utilization After Addition of Fremanezumab for Preventive Treatment in Patients Using Gepants for Acute Treatment of Migraine: Results From a Retrospective Chart Review

Article

Author: Krasenbaum, Lynda J ; Carr, Karen ; Driessen, Maurice T ; Saikali, Nicolas P ; Eugeni, Patrick ; Niu, Zhongzheng ; McVige, Jennifer W ; Seminerio, Michael J ; Rooney, Megan E

INTRODUCTION:

Fremanezumab, a monoclonal antibody (mAb) targeting the calcitonin gene-related peptide (CGRP) pathway, and gepants, small molecule CGRP receptor antagonists, are both approved for the treatment of migraine or its symptoms. This study assessed effectiveness, tolerability, and migraine-related healthcare resource utilization (HCRU) after the addition of fremanezumab for preventive migraine treatment in patients using gepants for acute treatment.

METHODS:

Data were extracted during a retrospective chart review from electronic medical records from the Dent Neurologic Institute. Eligible patients were ≥ 18 years old, using gepants (rimegepant or ubrogepant), who initiated fremanezumab between January 1, 2020, and May 1, 2021 (index date: date of fremanezumab initiation) and continued concomitant use of gepants and fremanezumab for ≥ 1 month (post-index; between 7-9 months of follow-up). Outcomes included monthly migraine days (MMD), adverse events (AEs), reasons for discontinuation, and migraine-related HCRU.

RESULTS:

A total of 55 patients [female, 93%; mean (SD) age, 43.5 (13.5) years] met the inclusion criteria. All patients were diagnosed with chronic migraine. Patients had an average (SD) MMD of 15.8 (7.4) at the index date. Average (SE) change in MMD from index date to post-index was - 6.5 (1.0) days (p < 0.0001). Five patients (9.1%) experienced AEs post-index; no serious AEs (SAEs) were reported. The number of migraine-related medications used decreased from the index date to post-index by a mean of 0.6 for preventive medications (p = 0.070), and 0.8 for acute medications (p = 0.050). The number of outpatient office-based visits also decreased [mean (SD): 6 months pre-index, 5.8 (4.4) vs. 6 months post-index, 4.1 (4.0); p < 0.0001].

CONCLUSION:

The addition of fremanezumab preventively to gepants for acute migraine treatment was effective, resulted in fewer outpatient office visits, and yielded no SAEs or AEs that were novel to these migraine medication classes.

01 Dec 2024·CNS & Neurological Disorders-Drug Targets

Safety and Efficacy of Calcitonin Gene-related Peptide Receptor Antagonists and Selective Serotonin Receptor Agonist in the Management of Migraine: A Systematic Review and Meta-analysis

Review

Author: Datusalia, Ashok Kumar ; Singh, Pooja ; Kumar, Anoop ; Ponnada, Rakesh Kumar ; Sharma, Ruchika ; Sumadhura, Bommaraju

Background::

Recently, US Food and Drug Administration (FDA) has approved calcitonin gene-related peptide receptor antagonists (rimegepant, and ubrogepant), and selective serotonin receptor agonists (lasmiditan) in the management of migraine. However, the exact safety and efficacy profile of these drugs is unclear so far.

Methods::

The study’s primary objective was to determine the exact safety and efficacy profile. The overall estimate was calculated in terms of risk ratios using a suitable model. The subgroup analysis was also performed to check the effect of individual drugs on the outcome, whereas sensitivity analysis was performed to check the effects of outliers on the outcome. All the analyses were performed using Rev Man 5. The drugs have shown significant improvement in efficacy parameters (pain freedom, most bothersome symptoms, phonophobia, nausea, and photophobia).

Results::

The subgroup analysis results have shown significant improvement in all efficacy parameters in the rimegepant and ubrogepant groups. The effect of ubrogepant on safety parameters was found to be non-significant, indicating a better safety profile of ubrogepant than lasmiditan.

Conclusion::

The sensitivity analysis results have shown no effect of outliers on the efficacy parameters. Based on the available evidence, recently approved drugs are effective in the treatment of migraine, however, associated with few adverse drug reactions.

25 Nov 2024·CARDIOVASCULAR RESEARCH

Crucial role for sensory nerves and Na/H exchanger inhibition in dapagliflozin- and empagliflozin-induced arterial relaxation

Article

Author: Forrester, Elizabeth A ; Jepps, Thomas A ; Salles-Crawley, Isabelle ; Redford, Kaitlyn E ; Barrese, Vincenzo ; Albert, Anthony P ; Rosenbaum, Tamara ; Dannesboe, Johs ; Dora, Kim ; Abbott, Geoffrey W ; Greenwood, Iain A ; Benítez-Angeles, Miguel

Abstract:

Aims:

Sodium/glucose transporter 2 (SGLT2 or SLC5A2) inhibitors lower blood glucose and are also approved treatments for heart failure independent of raised glucose. Various studies have showed that SGLT2 inhibitors relax arteries, but the underlying mechanisms are poorly understood and responses variable across arterial beds. We speculated that SGLT2 inhibitor-mediated arterial relaxation is dependent upon calcitonin gene-related peptide (CGRP) released from sensory nerves independent of glucose transport.

Methods and results:

The functional effects of SGLT1 and 2 inhibitors (mizagliflozin, dapagliflozin, and empagliflozin) and the sodium/hydrogen exchanger 1 (NHE1) blocker cariporide were determined on pre-contracted resistance arteries (mesenteric and cardiac septal arteries) as well as main renal conduit arteries from male Wistar rats using wire myography. SGLT2, CGRP, TRPV1, and NHE1 expression was determined by western blot and immunohistochemistry. Kv7.4/5/KCNE4 and TRPV1 currents were measured in the presence and absence of dapagliflozin and empagliflozin. All SGLT inhibitors (1–100 µM) and cariporide (30 µM) relaxed mesenteric arteries but had negligible effect on renal or septal arteries. Immunohistochemistry with TRPV1 and CGRP antibodies revealed a dense innervation of sensory nerves in mesenteric arteries that were absent in renal and septal arteries. Consistent with a greater sensory nerve component, the TRPV1 agonist capsaicin relaxed mesenteric arteries more effectively than renal or septal arteries. In mesenteric arteries, relaxations to dapagliflozin, empagliflozin, and cariporide were attenuated by the CGRP receptor antagonist BIBN-4096, depletion of sensory nerves with capsaicin, and blockade of TRPV1 or Kv7 channels. Neither dapagliflozin nor empagliflozin activated heterologously expressed TRPV1 channels or Kv7 channels directly. Sensory nerves also expressed NHE1 but not SGLT2 and cariporide pre-application as well as knockdown of NHE1 by translation stop morpholinos prevented the relaxant response to SGLT2 inhibitors.

Conclusion:

SGLT2 inhibitors relax mesenteric arteries by promoting the release of CGRP from sensory nerves in a NHE1-dependent manner.

News (Medical) associated with Ubrogepant

31 Jan 2025

·www.prnewswire.com

AbbVie Reports Full-Year and Fourth-Quarter 2024 Financial Results

Reports Full-Year Diluted EPS of $2.39 on a GAAP Basis, a Decrease of 12.1 Percent; Adjusted Diluted EPS of $10.12, a Decrease of 8.9 Percent; These Results Include an Unfavorable Impact of $1.52 Per Share Related to 2024 Acquired IPR&D and Milestones Expense Delivers Full-Year Net Revenues of $56.334 Billion, an Increase of 3.7 Percent on a Reported Basis and 4.6 Percent on an Operational Basis Full-Year Global Net Revenues from the Immunology Portfolio Were $26.682 Billion, an Increase of 2.1 Percent on a Reported Basis, or 2.9 Percent on an Operational Basis; Global Humira Net Revenues Were $8.993 Billion; Global Skyrizi Net Revenues Were $11.718 Billion; Global Rinvoq Net Revenues Were $5.971 Billion Full-Year Global Net Revenues from the Oncology Portfolio Were $6.555 Billion, an Increase of 10.8 Percent on a Reported Basis, or 12.0 Percent on an Operational Basis; Global Imbruvica Net Revenues Were $3.347 Billion; Global Venclexta Net Revenues Were $2.583 Billion Full-Year Global Net Revenues from the Neuroscience Portfolio Were $8.999 Billion, an Increase of 16.6 Percent on a Reported Basis, or 16.9 Percent on an Operational Basis; Global Botox Therapeutic Net Revenues Were $3.283 Billion; Global Vraylar Net Revenues Were $3.267 Billion; Combined Global Ubrelvy and Qulipta Net Revenues were $1.664 Billion Full-Year Global Net Revenues from the Aesthetics Portfolio Were $5.176 Billion, a Decrease of 2.2 Percent on a Reported Basis, or 0.6 Percent on an Operational Basis; Global Botox Cosmetic Net Revenues Were $2.720 Billion; Global Juvederm Net Revenues Were $1.177 Billion Reports Fourth-Quarter Diluted Loss Per Share of $0.02 on a GAAP Basis, Inclusive of the Recent Partial Intangible Asset Impairment Charge Related to Emraclidine; Adjusted Diluted EPS of $2.16; These Results Include an Unfavorable Impact of $0.88 Per Share Related to Fourth-Quarter 2024 Acquired IPR&D and Milestones Expense Delivers Fourth-Quarter Net Revenues of $15.102 Billion, an Increase of 5.6 Percent on a Reported Basis and 6.1 Percent on an Operational Basis Provides 2025 Adjusted Diluted EPS Guidance Range of $12.12 to $12.32; Excludes Any Unfavorable Impact Related to Acquired IPR&D and Milestones Expense Reaffirms Expectations for High Single-Digit Compound Annual Revenue Growth Rate through 2029; Raises 2027 Combined Sales Outlook for Skyrizi and Rinvoq to More Than $31 Billion; Updates Outlook for Aesthetics to Deliver High Single-Digit Compound Annual Revenue Growth Rate from 2025 through 2029 NORTH CHICAGO, Ill., Jan. 31, 2025 /PRNewswire/ -- AbbVie (NYSE:ABBV) announced financial results for the fourth quarter and full year ended December 31, 2024. "2024 was a year of significant progress for AbbVie. Our growth platform delivered outstanding results, we advanced our pipeline with key regulatory approvals and promising data, and we strengthened our business through strategic transactions," said Robert A. Michael, chief executive officer, AbbVie. "We are entering 2025 with significant momentum and expect net revenues to exceed their previous peak in just the second full year following the U.S. Humira loss of exclusivity." Fourth -Quarter Results Worldwide net revenues were $15.102 billion, an increase of 5.6 percent on a reported basis, or 6.1 percent on an operational basis. Global net revenues from the immunology portfolio were $7.294 billion, an increase of 4.9 percent on a reported basis, or 5.3 percent on an operational basis. Global Humira net revenues of $1.682 billion decreased 49.1 percent on a reported basis, or 48.7 percent on an operational basis. U.S. Humira net revenues were $1.246 billion, a decrease of 54.5 percent. Internationally, Humira net revenues were $436 million, a decrease of 22.7 percent on a reported basis, or 20.5 percent on an operational basis. Global Skyrizi net revenues were $3.778 billion, an increase of 57.7 percent on a reported basis, or 57.9 percent on an operational basis. Global Rinvoq net revenues were $1.834 billion, an increase of 46.2 percent on a reported basis, or 47.1 percent on an operational basis. Global net revenues from the oncology portfolio were $1.691 billion, an increase of 12.0 percent on a reported basis, or 12.9 percent on an operational basis. Global Imbruvica net revenues were $848 million, a decrease of 6.2 percent, with U.S. net revenues of $625 million and international profit sharing of $223 million. Global Venclexta net revenues were $655 million, an increase of 11.0 percent on a reported basis, or 13.0 percent on an operational basis. Global Elahere net revenues were $148 million. Global net revenues from the neuroscience portfolio were $2.509 billion, an increase of 19.8 percent on a reported basis, or 19.9 percent on an operational basis. Global Botox Therapeutic net revenues were $873 million, an increase of 12.5 percent on a reported basis, or 13.0 percent on an operational basis. Global Vraylar net revenues were $924 million, an increase of 17.1 percent. Global Ubrelvy net revenues were $303 million, an increase of 29.6 percent. Global Qulipta net revenues were $201 million, an increase of 76.4 percent on a reported basis, or 76.2 percent on an operational basis. Global net revenues from the aesthetics portfolio were $1.298 billion, a decrease of 5.2 percent on a reported basis, or 4.4 percent on an operational basis. Global Botox Cosmetic net revenues were $687 million, a decrease of 4.2 percent on a reported basis, or 3.4 percent on an operational basis. Global Juvederm net revenues were $279 million, a decrease of 16.3 percent on a reported basis, or 15.1 percent on an operational basis. On a GAAP basis, the gross margin ratio in the fourth quarter was 70.9 percent. The adjusted gross margin ratio was 83.8 percent. On a GAAP basis, selling, general and administrative (SG&A) expense was 25.5 percent of net revenues. The adjusted SG&A expense was 23.6 percent of net revenues. On a GAAP basis, research and development (R&D) expense was 44.9 percent of net revenues. The adjusted R&D expense was 15.1 percent of net revenues. Acquired IPR&D and milestones expense was 10.4 percent of net revenues. On a GAAP basis, the operating margin in the fourth quarter was negative 9.9 percent. The adjusted operating margin was 34.7 percent. Net interest expense was $610 million. On a GAAP basis, the tax rate in the quarter was 99.0 percent. The adjusted tax rate was 20.2 percent. Diluted loss per share in the fourth quarter was $0.02 on a GAAP basis, inclusive of the recent partial intangible asset impairment charge related to emraclidine. Adjusted diluted EPS, excluding specified items, was $2.16. These results include an unfavorable impact of $0.88 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 the European Commission (EC) granted marketing authorization for Elahere (mirvetuximab soravtansine) for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant high grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer who have received one to three prior systemic treatment regimens. Elahere is the first novel therapy approved in the European Union (EU) specifically for patients with FRα positive, platinum-resistant ovarian cancer. At the American Society of Hematology (ASH) Annual Meeting, AbbVie announced updated clinical trial results that showed Epkinly (epcoritamab) combination therapy demonstrated high response rates in adult patients with relapsed or refractory (r/r) follicular lymphoma (FL). The company also announced new results from two ongoing clinical trials which showed Epkinly induced durable complete responses as monotherapy and combination treatment in patients with diffuse large B-cell lymphoma (DLBCL). Epkinly is being co-developed by AbbVie and Genmab. AbbVie and EvolveImmune Therapeutics, an immuno-oncology company developing next-generation biotherapeutics to overcome the therapeutic challenges of cancer cell resistance to current immunotherapies, announced a collaboration and option-to-license agreement to develop multispecific biologics for multiple targets in oncology. The discovery partnership will leverage AbbVie's oncology expertise and EvolveImmune's T-cell engager platform to develop novel antibody-based therapies for solid and hematologic malignancies. AbbVie and Simcere Zaiming announced a partnership to develop a novel trispecific antibody candidate in multiple myeloma (MM). This option-to-license agreement will develop SIM0500, an investigational new drug candidate that is currently in Phase 1 clinical trials in patients with r/r MM. AbbVie and Neomorph announced a collaboration and license agreement that will leverage AbbVie's drug development expertise and Neomorph's leading molecular glue discovery platform to develop novel molecular glue degraders for multiple targets across oncology and immunology. AbbVie announced that it completed its acquisition of Nimble Therapeutics, strengthening AbbVie's pipeline and R&D capabilities. The transaction includes Nimble's lead asset, an investigational oral peptide IL23R inhibitor in preclinical development for the treatment of psoriasis (PsO) as well as Nimble's peptide synthesis, screening, and optimization platform used to help drive rapid discovery and optimization of peptide candidates for a range of targets. AbbVie announced positive topline results from its pivotal Phase 3 TEMPO-2 trial evaluating tavapadon as a flexible-dose monotherapy in early Parkinson's disease (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. Tavapadon has demonstrated positive results across all three Phase 3 TEMPO trials and AbbVie remains on track to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) later this year. AbbVie announced that its two Phase 2 EMPOWER trials investigating emraclidine as a once-daily, oral monotherapy treatment for adults with schizophrenia who are experiencing an acute exacerbation of psychotic symptoms, did not meet their primary endpoint of showing a statistically significant reduction (improvement) in the change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score compared to the placebo group at week 6. Following the results of these trials, AbbVie began an evaluation of the emraclidine intangible asset for impairment which resulted in a significant decrease in the estimated future cash flows for the product. Based on the revised cash flows, the company recorded a non-cash after-tax intangible asset impairment charge of $3.5 billion. AbbVie continues to evaluate information with respect to the Cerevel-related clinical development programs and will monitor the remaining intangible assets of $3.6 billion. AbbVie announced that it completed its acquisition of Aliada Therapeutics. The transaction strengthens AbbVie's neuroscience pipeline and R&D capabilities with the addition of a potential best-in-class disease-modifying therapy for Alzheimer's disease (AD), ALIA-1758, and novel blood-brain barrier (BBB)-crossing technology. Full-Year 2025 Outlook AbbVie is issuing its adjusted diluted EPS guidance for the full-year 2025 of $12.12 to $12.32. The company's 2025 adjusted diluted EPS guidance excludes any impact from acquired IPR&D and milestones that may be incurred during 2025, as both cannot be reliably forecasted. Long-Term Outlook AbbVie is reaffirming its expectations for a high single-digit compound annual revenue growth rate through 2029. This guidance assumes 2024 as the base year in the compound annual growth rate calculation. AbbVie is raising its long-term outlook for Skyrizi and Rinvoq revenues. The company now expects combined Skyrizi and Rinvoq 2027 revenues of more than $31 billion, an increase of approximately $4 billion compared to previous guidance for combined revenues of more than $27 billion in 2027. This guidance assumes Skyrizi revenues of more than $20 billion and Rinvoq revenues of more than $11 billion in 2027. AbbVie is also updating its outlook for aesthetics revenues. The company now expects a high single-digit compound annual revenue growth rate for aesthetics through 2029. This guidance assumes 2025 as the base year in the compound annual growth rate calculation. 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 fourth-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/inPhase 1

27 Nov 2024

·www.businesswire.com

AbbVie Digital Transformation Strategy Report 2024 - Accelerators, Incubators and Other Innovation Programs - ResearchAndMarkets.com

DUBLIN--( BUSINESS WIRE )--The "Enterprise Tech Ecosystem Series: AbbVie Inc. - 2024" company profile has been added to ResearchAndMarkets.com's offering. The report provides insights into AbbVie's tech activities, including its digital transformation strategies, its innovation programs, and its technology initiatives. The report provides information and insights into AbbVie's tech activities, including: Insights of its digital transformation strategies and innovation programs. Overview of technology initiatives covering partnerships and product launches. Insights on each technology initiative including technology theme, objective, and benefits. Details of estimated ICT budgets and major ICT contracts. AbbVie Inc. (AbbVie) is a multi-national, diversified research-based biopharmaceutical company engaged in developing, manufacturing, marketing, and selling medicines for serious and complex diseases. The company's product portfolio includes immunology products, oncology products, aesthetics products, neuroscience products, and eye care products. AbbVie's immunology product portfolio includes Humira, Skyrizi, and Rinvoq. Its oncology product portfolio includes Imbruvica, Venclexta, Epkinly, and Elahere. Its aesthetics product portfolio includes Botox Cosmetic, the Juvederm Collection of Fillers, Alloderm regenerative dermal tissue, and Latisse eyelash solution, among others. Its neuroscience product portfolio includes Botox Therapeutic, Vraylar, Duopa, Ubrelvy, and Qulipta, and its eye care product portfolio includes Ozurdex, Lumigan, Alphagan, and Restasis. The company also manufactures medicines for treating hepatitis C virus infection, metabolic and hormonal diseases, and endocrinology diseases. AbbVie sells its products directly to distributors, wholesalers, healthcare facilities, government agencies, independent retailers, and specialty pharmacies across the world. Reasons to Buy Gain insights into AbbVie's tech operations. Gain insights into its tech strategies and innovation initiatives. Gain insights into its technology themes under focus. Gain insights into various product launches and partnerships. Key Topics Covered: Overview Digital Transformation Strategy Accelerators, Incubators, and Other Innovation Programs Technology Focus Technology Initiatives Partnerships Network Map ICT Budget and Contracts Key Executives A selection of companies mentioned in this report includes: Reltio ConcertAI Caris Life Sciences BigHat Biosciences Cerebras Systems Accenture Pegasystems NowVertical Chronicled MC10 For more information about this company profile visit https://www.researchandmarkets.com/r/2mdpyj About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

11 Nov 2024

·www.biopharmadive.com

AbbVie’s $9B bet collapses as closely watched schizophrenia drug fails studies

AbbVie lost about $40 billion in market value Monday morning after an experimental drug the company had bet heavily on failed two important clinical trials.The drug, called emraclidine, was developed by Pfizer spinout Cerevel Therapeutics, which AbbVie recently acquired for almost $9 billion. Its one of a new class of brain-balancing medications researchers see as valuable tools for treating a variety of psychiatric conditions. With emraclidine, Cerevel chose schizophrenia as the first target, and over the past couple of years has been running a pair of studies to assess whether the drug can quickly alleviate symptoms of the disorder.AbbVie has now disclosed the studies did not succeed. Three doses of the drug were tested, and neither performed significantly better than a placebo after six weeks of treatment. The trials together enrolled around 750 participants, and evaluated them with a well-known scale used to measure the different symptoms people with schizophrenia experience, from positive ones like excitement and hallucinations to negative ones like emotional withdrawal.“While we are disappointed with the results, we are continuing to analyze the data to determine next steps,“ said Roopal Thakkar, AbbVies chief scientific officer,in the companys statement.The Illinois-based pharmaceutical giant said neuroscience remains one of its key focus areas. Just last month, AbbVie announced plans to spend $1.4 billion buying a startup with an experimental treatment for Alzheimers disease.The company also noted how it gained an entire pipeline of drug programs from the Cerevel acquisition, with multiple clinical-stage and preclinical candidates that complement its existing portfolio of brain medicines. Net revenue from that portfolio, which includes Botox, the antipsychotic Vraylar and the migraine medication Ubrelvy, totaled almost $6.5 billion over the first nine months of this year.One such Cerevel drug, a Parkinsons treatment called tavapadon, defied analyst expectations by succeeding in a late-stage trial earlier this year.Still, AbbVie investors may not see much of a silver lining. Company shares were down more than 12% Monday morning, representing one of the largest single-day dips involving a big pharma stock over the past year.This is disappointing and unexpected, wrote Louise Chen, an analyst at the investment firm Cantor Fitzgerald, in a note to clients.In an earlier, much smaller schizophrenia trial, researchers found two doses of emraclidine each beat a placebo at reducing scores on the same symptoms scale used in the Phase 2 studies.Additionally, emraclidine works in a similar way to Cobenfy, an antipsychotic medication that succeeded in three medium- to large-sized clinical trials before receiving Food and Drug Administration approval in September. Less than three weeks after AbbVie announced its Cerevel acquisition, Bristol Myers Squibb agreed to buy Cobenfys developer, Karuna Therapeutics, for $14 billion.Schizophrenia patients switch medications often, either because they carry side effects like weight gain or because they arent properly controlling the disease. Clinical testing of Cobenfy showed it doesnt cause some of the more challenging side effects seen with other antipsychotics. That, plus Cobenfys ability to act quickly, has led both Bristol Myers and Wall Street analysts to expect billions of dollars in peak annual sales from the drug.Shares of Bristol Myers were up almost 12% late Monday morning.Olivia Brayer, an analyst at Cantor who covers the company, argues that emraclidines failure removes a major overhang for Cobenfy, as its biggest competitive threat in schizophrenia is no longer.The Cerevel acquisition just went up in flames, Brayer wrote in a note to clients, adding that her team has been getting questions about how Bristol Myers stock could move based on the results of AbbVies two studies. But an outright failure wasn't on anyone's bingo card. '

AcquisitionPhase 2Drug ApprovalClinical Result

100 Deals associated with Ubrogepant

External Link

KEGG	Wiki	ATC	Drug Bank
D10673	Ubrogepant	N02C	DB15328

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Migraine Disorders	US	AbbVie, Inc.	23 Dec 2019

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Migraine With Aura	Phase 3	US	AbbVie, Inc.	13 Jan 2022
Migraine With Aura	Phase 3	PR	AbbVie, Inc.	13 Jan 2022
Acute migraine	Phase 2	-	Allergan Ltd. (Ireland)	01 Jul 2012

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05264129 (TANDEM, CTgov)	Phase 4	Migraine Disorders	263	Atogepant (Atogepant 60 mg (Period 1))	tyuenzuean(fvlfuijzxp) = fflyzyepdp bcwlxilrkt (iasshybqqr, ggptxkhrdn - iccfxsoxxl) View more	-	08 Oct 2024
				Atogepant+Ubrogepant (Atogepant 60 mg + Ubrogepant 100 mg (Period 2))	tyuenzuean(fvlfuijzxp) = lgcjnjqtpn bcwlxilrkt (iasshybqqr, clbkcuurie - zuahhsdprr) View more
NCT04492020 (PRODROME, Literature) Manual	Phase 3	Migraine Disorders	518	Ubrogepant	umbabypetz(daarcfyhzf): OR = 1.66 (95% CI, 1.40 - 1.96), P-Value = < 0.0001 View more	Positive	28 Aug 2024
				Placebo
AAN2024	Phase 1	Migraine Disorders	8	Ubrogepant 100 mg	kwkfyhbbgs(fktaixjaiv) = ubetfcenyf uiuaocainh (besabtllou )	Positive	09 Apr 2024
NCT05264129 (TANDEM, AAN2024)	Phase 4	Migraine Disorders \| Acute migraine calcitonin gene-related peptide (CGRP) receptor antagonist	263	Atogepant 60mg QD	qbwnisyoug(bsovotzrgh) = 8.4% vs 3.2% kakcvhhkvu (vokmxxrycv ) View more	Positive	09 Apr 2024
				Ubrogepant 100mg PRN
NCT04492020 (PRODROME, Literature \| Pubmed \| Lancet) Manual	Phase 3	Migraine Disorders	518	Ubrogepant	xckugvysoh(xqagcrdbot) = lvmtyodepy wssjugdlgr (soqffyiojp ) View more	Positive	15 Nov 2023
				placebo	xckugvysoh(xqagcrdbot) = fjhyqsakwa wssjugdlgr (soqffyiojp ) View more
NCT04492020 (PRODROME, AAN2023)	Phase 3	Migraine Disorders calcitonin gene-related peptide (CGRP) receptor	-	Ubrogepant 100 mg	xphcyszfeh(grvbcscfib) = hsrkncvyor fuoprxfoqk (ksyqhrglzb ) View more	-	25 Apr 2023
				Placebo	xphcyszfeh(grvbcscfib) = uxwczaphoz fuoprxfoqk (ksyqhrglzb ) View more
NCT03461757 \| NCT02828020 \| NCT02867709 \| NCT02439320 \| NCT02605174 (Pubmed \| Clin J Pain)	Phase 3	Migraine Disorders	-	Rimegepant 75 mg	sxtvoywqsg(xvgwquzbst) = mjexjwwsgl tmoenjgztu (yrghenxzyo, 5 - 12) View more	-	01 Nov 2022
				Ubrogepant 100 mg	zskgovmumh(owchvvjlvx) = vftfhipplt lawvzdkzmy (roqwnbuopq, 4 - 8)
NCT02873221 (Pubmed)	Phase 3	Migraine Disorders	808	Ubrogepant-50mg	ruvjizqine(sbzlxqqjnn) = zrqdtkfeoy okfgtvohys (fxfgxfzqtk )	-	17 Aug 2022
				Ubrogepant-100mg	ruvjizqine(sbzlxqqjnn) = ssnbhehtzz okfgtvohys (fxfgxfzqtk )
AAN2022	Phase 3	-	490	Ubrogepant 50mg	nacrfditru(zzbzjmcphb) = cahybyjsls wtstecvxqq (bicvogdlwk ) View more	-	03 May 2022
				Ubrogepant 100mg	nacrfditru(zzbzjmcphb) = fgjdrswlyg wtstecvxqq (bicvogdlwk ) View more

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