Chronic leukemia

Beckman Coulter Life Sciences has received 510(k) clearance from the Food and Drug Administration (FDA) to distribute its DxFLEX Clinical Flow Cytometer in the United States. Launched regionally in 2020, this brings the popular benchtop IVD flow cytometry system to American labs while expanding testing capabilities. Offering up to 13-colours, additional detectors can be activated as laboratory needs evolve without the need to purchase additional hardware. “This pioneering advancement puts high-complexity flow cytometry testing within reach to more laboratories without added expense,” said Carsten Lange, product manager. “The DxFLEX Clinical Flow Cytometer adds more colours without adding more concerns, and enables laboratory staff to have greater confidence in results, while streamlining workflows and reducing manual steps. With more fluorescence parameters, laboratories can get more out of specimens and avoid a tedious compensation process and the burden that places on lab staff.” The compact DxFLEX Flow Cytometer makes multicolour flow cytometry less complex by using avalanche photodiode (APD) detector technology instead of traditional photomultiplier tube (PMT) technology. The use of APD technology simplifies compensation procedures and delivers richer content analysis with higher sensitivity to find dim populations. The compensation library simplifies compensation setup, while easy-to-learn CytExpert software lowers labour time and enables work to begin right out of the box for novice users. The compact DxFLEX Flow Cytometer is available in two configurations, from a three-laser/10-colour system to a three-laser/13- colour configuration. The DxFLEX Flow Cytometer is validated as an in vitro diagnostic device for 10-colour immunophenotyping with the ClearLLab 10C Reagent System and delivers the only FDA cleared and CE marked integrated leukemia and lymphoma solution, which offers all components needed, from quality controls, sample preparation and antibody panels to analysis software and training material. This enables workflows for diseases such as chronic leukemia, myeloma, acute leukemia, non-Hodgkin lymphoma, myeloproliferative neoplasm, and myelodysplastic syndrome.

Submissions are supported by two Phase 3 clinical trials demonstrating risankizumab achieved the primary endpoint of clinical remission (per Adapted Mayo Score) and key secondary endpoints as an induction and maintenance treatment1,2 Safety results were generally consistent with the known safety profile of risankizumab, with no new safety risks observed1,2 Risankizumab is an IL-23 inhibitor being evaluated as a treatment for adults with moderately to severely active ulcerative colitis and is currently approved by FDA and EMA in Crohn's disease, psoriatic arthritis and psoriasis1 NORTH CHICAGO, Ill., Aug. 28, 2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that it has submitted applications for a new indication to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for risankizumab (SKYRIZI®, 1200 mg intravenous [IV] [induction dose] and 180 mg and 360 mg subcutaneous [SC] [maintenance dose]) for the treatment of adult patients with moderately to severely active ulcerative colitis. "While there has been advancement in therapies to treat ulcerative colitis, there is still an ongoing need for additional treatments to help those seeking relief from its disruptive effects," said Roopal Thakkar, M.D., senior vice president, development, regulatory affairs and chief medical officer, AbbVie. "These submissions demonstrate our continued commitment to helping people living with IBD, and we look forward to providing a potential new treatment option for the management of ulcerative colitis." Applications to the FDA and EMA are supported by data from two Phase 3 clinical trials: an induction study, INSPIRE, and a maintenance study, COMMAND.1,2 Significantly more patients treated with risankizumab 1200 mg IV at week 12 in the induction study and 180 mg or 360 mg SC at week 52 in the maintenance study achieved the primary endpoint of clinical remission (per Adapted Mayo Score), compared to patients receiving placebo.1,2 Additionally, more risankizumab-treated patients in both the induction and maintenance studies achieved the key secondary endpoints of endoscopic improvement (endoscopic subscore ≤1 without evidence of friability) and histologic endoscopic mucosal improvement (HEMI, defined as endoscopic subscore ≤1 without evidence of friability and Geboes score ≤3.1) compared to placebo.1,2 The safety results in INSPIRE and COMMAND were generally consistent with the safety profile of risankizumab observed in previous studies across other indications, with no new safety risks observed.1,2 Risankizumab (SKYRIZI) is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally. About Ulcerative Colitis Ulcerative colitis is a chronic, idiopathic, immune-mediated inflammatory bowel disease (IBD) of the large intestine that causes continuous mucosal inflammation extending, to a variable extent, from the rectum to the more proximal colon.3,4 The hallmark signs and symptoms of ulcerative colitis include rectal bleeding, abdominal pain, bloody diarrhea, tenesmus (a sense of pressure), urgency and fecal incontinence.3,4 The disease course of ulcerative colitis varies between patients and can range from quiescent disease to chronic refractory disease, which in some cases can lead to surgery or life-threatening complications.5,6 The severity of symptoms and unpredictability of disease course can lead to substantial burden and often disability among those living with the disease.7 About INSPIRE Induction Study1 INSPIRE is a multicenter, randomized, double-blind, placebo-controlled Phase 3 study evaluating the efficacy and safety of risankizumab 1200 mg IV administered every four weeks as induction therapy in subjects with moderately to severely active ulcerative colitis. The primary endpoint is clinical remission (per adapted Mayo Score, defined as SFS ≤1 and not greater than baseline, RBS of 0 and endoscopic subscore ≤1 without friability) at week 12. Key secondary endpoints include clinical response (decrease from baseline in the Adapted Mayo score ≥2 points and ≥30% from baseline, plus a decrease in RBS ≥1 or an absolute RBS ≤1), endoscopic improvement (endoscopic subscore ≤1 without friability), and HEMI (endoscopic subscore of 0 or 1 without friability and Geboes score ≤3.1) at week 12. Topline results of the study were shared in March 2023. More information can be found on (NCT03398148). About COMMAND Maintenance Study2 The COMMAND study is a Phase 3, multicenter, randomized, double-blind, controlled, 52-week maintenance study designed to evaluate the efficacy and safety of risankizumab 180 mg or 360 mg SC in adults with moderately to severely active ulcerative colitis. This study had a re-randomized withdrawal design in which all patients received risankizumab IV induction and those who responded to risankizumab were re-randomized to receive risankizumab 180 mg or 360 mg SC or withdrawal from risankizumab treatment (induction-only control group). For those randomized to the withdrawal from risankizumab treatment (induction-only control group), the rest of the study duration was a risankizumab washout. The objective of the Phase 3 study is to evaluate the efficacy and safety of risankizumab 180 mg or 360 mg as maintenance therapy versus withdrawal from risankizumab treatment (control) in patients with moderately to severely active ulcerative colitis who responded to risankizumab IV induction in the INSPIRE study. The primary endpoint is clinical remission (per Adapted Mayo Score, defined as SFS ≤1 and not greater than baseline, RBS of 0 and endoscopic subscore ≤1 without evidence of friability) at week 52. Key secondary endpoints include endoscopic improvement (endoscopic subscore ≤1 without evidence of friability), HEMI (endoscopic subscore of ≤1 without evidence of friability and Geboes score ≤3.1), and steroid-free clinical remission (defined as clinical remission per Adapted Mayo Score at week 52 and corticosteroid free for ≥90 days prior to week 52) at week 52. Topline results from this study were shared in June 2023. More information can be found on (NCT03398135). About Risankizumab (SKYRIZI®) SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit.8 IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases.9 SKYRIZI is approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency for the treatment of plaque psoriasis, psoriatic arthritis and Crohn's disease. The use of risankizumab in ulcerative colitis is not approved and its safety and efficacy have not been established by regulatory authorities. Phase 3 trials of risankizumab in psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis are ongoing.9-11 U.S. Indications and Important Safety Information about SKYRIZI® (risankizumab-rzaa)12 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 AbbVie in Gastroenterology With a robust clinical trial program, AbbVie is committed to cutting-edge research to drive exciting developments in inflammatory bowel diseases (IBD), like ulcerative colitis and Crohn's disease. By innovating, learning and adapting, AbbVie aspires to eliminate the burden of IBD and make a positive long-term impact on the lives of people with IBD. For more information on AbbVie in gastroenterology, visit . About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions 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 in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. 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 2022 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. Data on File: ABVRRTI75696. AbbVie. Data on file: ABVRRTI76012. Gajendran M, Loganathan P, Jimenez G, et al. A comprehensive review and update on ulcerative colitis. Dis Mon. 2019;65(12):100851. doi:10.1016/j.disamonth.2019.02.004 The facts about inflammatory bowel diseases. Crohn's & Colitis Foundation of America. Accessed March 8, 2023. Ulcerative colitis. Mayo Clinic. Accessed March 3, 2023. Surgery for Crohn's Disease and Ulcerative Colitis. Crohn's & Colitis Foundation of America. Accessed August 21, 2023. Mehta F. Report: economic implications of inflammatory bowel disease and its management. Am J Manag Care. 2016;22(3 Suppl):s51-60. SKYRIZI [Summary of Product Characteristics]. AbbVie Ltd. Available at: . Accessed on August 21, 2023. Pipeline. AbbVie. Accessed March 3, 2023. A study comparing risankizumab to placebo in participants with active psoriatic arthritis including those who have a history of inadequate response or intolerance to biologic therapy(ies) (KEEPsAKE2). ClinicalTrials.gov. Updated February 28, 2023. Accessed March 3, 2023. 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. ClinicalTrials.gov. Updated March 10, 2023. Accessed March 12, 2023. SKYRIZI [package insert]. North Chicago, IL: AbbVie Inc.; 2022. SOURCE AbbVie

NORTH CHICAGO, IL, USA I June 15, 2023 I AbbVie (NYSE: ABBV ) today announced positive top-line results from COMMAND, its Phase 3 maintenance study, showing risankizumab (SKYRIZI ® , 180 mg or 360 mg subcutaneous [SC]) achieved the primary endpoint of clinical remission (per Adapted Mayo Score) at week 52, as well as key secondary endpoints in adult patients with moderately to severely active ulcerative colitis. 1 In the COMMAND maintenance study, patients from the Phase 2b/3 INSPIRE study who responded to induction treatment were re-randomized to receive risankizumab 180 mg SC, 360 mg SC or withdrawal from risankizumab treatment (risankizumab intravenous [IV] induction-only control group). 1 Approximately 75% of patients previously failed at least one advanced therapy (biologics, JAK inhibitors and/or S1P receptor modulators) for ulcerative colitis. 1 A significantly higher proportion of patients who received risankizumab 180 mg or 360 mg achieved clinical remission at week 52: 40% and 38%, respectively, compared to 25% in the induction-only control group (p<0.01). 1 "Through important programs such as the Phase 3 COMMAND study, we continue to drive research and development to help manage the impact of serious gastroenterological conditions," said Roopal Thakkar, M.D., senior vice president, development, regulatory affairs and chief medical officer, AbbVie. "Risankizumab is already approved in moderately to severely active Crohn's disease, and these results demonstrate that this treatment can be a potentially effective option for ulcerative colitis as well." In COMMAND, 51% of patients treated with risankizumab 180 mg and 48% of patients treated with risankizumab 360 mg achieved endoscopic improvement at week 52 vs 32% of patients in the induction-only control group (p<0.001). 1 Additionally, significantly more patients treated with risankizumab 180 mg and 360 mg achieved histologic endoscopic mucosal improvement at week 52 compared to those treated with induction only: 43% and 42%, respectively, vs 23% (p<0.001). 1 A significantly higher proportion of patients who received risankizumab 180 mg or 360 mg achieved steroid-free clinical remission compared to the induction-only control group at week 52 (40% and 37%, respectively, vs 25%; p<0.01). 1 "These positive results suggest that risankizumab is a promising therapy to help ulcerative colitis patients with challenging symptoms that disrupt their daily lives," said Stefan Schreiber, M.D., director of department of internal medicine I, University Hospital Schleswig-Holstein, Germany, COMMAND study investigator. "Risankizumab's achievement of a broad range of difficult-to-reach endpoints encompassing endoscopic-histologic outcomes and many others represents important progress toward addressing the need for additional treatment options for patients with ulcerative colitis." The safety profile of risankizumab in the 52-week, double-blind, placebo-controlled COMMAND study was consistent with the safety profile observed in previous studies across other indications, with no new safety risks observed. 1 The most common adverse events observed in the risankizumab groups were colitis ulcerative, COVID-19, nasopharyngitis and arthralgia. 1 Serious adverse events occurred in 5.2% and 5.1% of patients in the risankizumab 180 mg and 360 mg groups compared to 8.2% of patients in the control group. 1 There was one death in the 360 mg group due to adenocarcinoma assessed as unrelated to study drug . There were no adjudicated major adverse cardiac events (MACE) and no adjudicated anaphylactic reaction events. Full results from the COMMAND study will be presented at a future medical meeting and submitted for publication in a peer-reviewed journal. Use of risankizumab in ulcerative colitis is not approved and its safety and efficacy have not been evaluated by regulatory authorities. Risankizumab (SKYRIZI) is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally. About Ulcerative Colitis Ulcerative colitis is a chronic, idiopathic, immune-mediated inflammatory bowel disease (IBD) of the large intestine that causes continuous mucosal inflammation extending, to a variable extent, from the rectum to the more proximal colon. 2,3 The hallmark signs and symptoms of ulcerative colitis include rectal bleeding, abdominal pain, bloody diarrhea, tenesmus (a sense of pressure), urgency and fecal incontinence. 3,4 The disease course of ulcerative colitis varies between patients and can range from quiescent disease to chronic refractory disease, which in some cases can lead to surgery or complications, including cancer or death. 4,5 The severity of symptoms and unpredictability of disease course can lead to substantial burden and often disability among those living with the disease. 6 About COMMAND 1 The COMMAND study is a Phase 3, multicenter, randomized, double-blind, controlled, 52-week maintenance study designed to evaluate the efficacy and safety of risankizumab 180 mg or 360 mg SC in adults with moderately to severely active ulcerative colitis. This study had a re-randomized withdrawal design in which all patients received risankizumab IV induction and those who responded to risankizumab were re-randomized to receive risankizumab 180 mg or 360 mg SC or withdrawal from risankizumab treatment (induction-only control group). For those randomized to the withdrawal from risankizumab treatment (induction-only control group), the rest of the study duration was a risankizumab washout. The objective of the Phase 3 study is to evaluate the efficacy and safety of risankizumab 180 mg or 360 mg as maintenance therapy versus withdrawal from risankizumab treatment (control) in patients with moderately to severely active ulcerative colitis who responded to risankizumab IV induction in the INSPIRE study. The primary endpoint is clinical remission (per Adapted Mayo Score, defined as SFS ≤1 and not greater than baseline, RBS of 0 and endoscopic subscore ≤1 without evidence of friability) at week 52. Secondary endpoints include endoscopic improvement (endoscopic subscore ≤1 without evidence of friability), HEMI (endoscopic subscore of ≤1 without evidence of friability and Geboes score ≤3.1), and steroid-free clinical remission (defined as clinical remission per Adapted Mayo Score at week 52 and corticosteroid free for ≥90 days prior to week 52) at week 52. More information can be found on www.clinicaltrials.gov (NCT03398135). About Risankizumab (SKYRIZI ® ) SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit. 7 IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases. 8 SKYRIZI is approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency for the treatment of plaque psoriasis, psoriatic arthritis and Crohn's disease. Phase 3 trials of risankizumab in psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis are ongoing. 8,9,10 U.S. Indications and Important Safety Information about SKYRIZI ® (risankizumab-rzaa) 11 SKYRIZI is a prescription medicine used to treat adults with: 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 AbbVie in Gastroenterology With a robust clinical trial program, AbbVie is committed to cutting-edge research to drive exciting developments in inflammatory bowel diseases (IBD), like ulcerative colitis and Crohn's disease. By innovating, learning and adapting, AbbVie aspires to eliminate the burden of IBD and make a positive long-term impact on the lives of people with IBD. For more information on AbbVie in gastroenterology, visit https://www.abbvie.com/our-science/therapeutic-focus-areas/immunology/immunology-focus-areas/gastroenterology.html . 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, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , LinkedIn or Instagram . References: SOURCE: AbbVie