AbbVie Inc. reports pharmaceutical developments across immunology, neuroscience, oncology and Allergan Aesthetics. Recurring updates include financial results by product portfolio, clinical and real-world data for therapies such as SKYRIZI and RINVOQ, FDA regulatory submissions and response letters, and medical-conference presentations in inflammatory bowel disease and other immune-mediated conditions.
Company news also covers pipeline spending, acquired in-process research and development, manufacturing capacity for medicines in core therapeutic areas, and investor conference appearances. AbbVie’s product references commonly include SKYRIZI, RINVOQ, Botox Therapeutic, Vraylar, Ubrelvy, Qulipta, Venclexta, Imbruvica and Elahere.
AbbVie announced that The Lancet published results from three pivotal Phase 3 trials of upadacitinib (RINVOQ) for treating moderately to severely active ulcerative colitis. The U-ACHIEVE (induction), U-ACCOMPLISH, and U-ACHIEVE (maintenance) studies demonstrated the efficacy and safety of upadacitinib in patients with inadequate responses to prior therapies. The studies focused on clinical remission and endoscopic improvement over 8 weeks and 52 weeks. While RINVOQ is not yet approved in the EU, it is currently under review by global health authorities.
AbbVie (NYSE: ABBV) announced results from three pivotal Phase 3 clinical trials published in The Lancet, focusing on risankizumab (SKYRIZI) for treating moderately to severely active Crohn's disease. The ADVANCE and MOTIVATE studies evaluated induction therapy efficacy, while the FORTIFY study assessed maintenance therapy. Results showed significant improvements in clinical remission and endoscopic response. However, risankizumab's approval for Crohn's disease is pending, as safety and efficacy are under regulatory review.
Genmab (Nasdaq: GMAB) announced the acceptance of multiple abstracts for presentation at the 2022 ASCO Annual Meeting, showcasing investigational medicines from its pipeline. Key highlights include data from the phase 1b/2 EPCORE™ NHL-2 trial evaluating epcoritamab (DuoBody-CD3xCD20) in B-cell non-Hodgkin lymphoma and an oral presentation of tisotumab vedotin in recurrent or metastatic cervical cancer. The findings reinforce Genmab's commitment to delivering innovative therapies, with partnerships alongside AbbVie (ABBV) and Seagen (SGEN).
AbbVie (NYSE: ABBV) will participate in the Bernstein 38th Annual Strategic Decisions Conference on June 1, 2022, at 10:00 a.m. Central Time. Richard A. Gonzalez, chairman and CEO, will present. A live audio webcast will be available on AbbVie's Investor Relations website, with an archived version accessible later the same day.
AbbVie focuses on discovering and delivering innovative medicines across various therapeutic areas, including immunology, oncology, and neurology. For more information, visit www.abbvie.com.
AbbVie (NYSE: ABBV) announced significant data presentations at the EULAR 2022 Congress, highlighting the efficacy and safety of its treatments, including upadacitinib (RINVOQ) and risankizumab (SKYRIZI). Key studies include SELECT-AXIS 2, showcasing RINVOQ in axial spondyloarthritis, and SELECT-PsA 1 & 2, demonstrating its impact on psoriatic arthritis patients. The congress will feature 25 posters, 3 oral presentations, and insights from various clinical trials, underscoring AbbVie's commitment to advancing rheumatic disease management.
AbbVie announced positive results from Study 3111-301-001, where cariprazine (VRAYLAR) demonstrated statistically significant improvement in major depressive disorder (MDD) patients inadequately responsive to current antidepressants. The study achieved its primary endpoint based on the Montgomery-Åsberg Depression Rating Scale (MADRS), with p-value 0.0050. The FDA is reviewing AbbVie's supplemental New Drug Application (sNDA) for cariprazine's expanded use in MDD, with a decision expected by year-end. The safety profile remained consistent with previous studies, with no deaths reported and manageable adverse events.
AbbVie announced that the European Medicines Agency's CHMP has issued a positive opinion recommending the approval of upadacitinib (RINVOQ) for treating adults with moderately to severely active ulcerative colitis (UC). This recommendation is supported by data from three Phase 3 studies, showing significant clinical remission rates compared to placebo. If approved by the European Commission, this would mark the fifth indication for upadacitinib in the EU, with a decision expected in Q3 2022.
AbbVie has submitted a New Drug Application (NDA) to the FDA for ABBV-951 (foscarbidopa/foslevodopa) to treat motor fluctuations in advanced Parkinson's disease. This application is supported by a Phase 3 study showing significant improvement in "On" time without troublesome dyskinesia compared to oral carbidopa/levodopa. ABBV-951 aims to provide continuous subcutaneous delivery, enhancing symptom control. The study involved around 130 participants across the U.S. and Australia, with mostly mild adverse events reported. AbbVie plans further regulatory submissions internationally.
AbbVie will present 27 abstracts at the Digestive Disease Week (DDW) Annual Meeting from May 21-24, 2022, highlighting its leadership in gastroenterology research, especially in inflammatory bowel disease (IBD) and irritable bowel syndrome (IBS).
Key presentations will include data from Phase 3 studies of RINVOQ (upadacitinib) for ulcerative colitis and Crohn's disease. A late-breaking presentation will focus on the effectiveness of upadacitinib in Crohn's patients who have not responded to previous biologics.
AbbVie has secured an exclusive worldwide license option for CUG252, a Treg-selective IL-2 mutein from Cugene, aimed at treating autoimmune and inflammatory diseases. The agreement requires Cugene to conduct a Phase 1a study and a Phase 1b study during the option period. AbbVie will pay an upfront fee of $48.5 million and could incur further milestone payments. This partnership underscores AbbVie's commitment to developing innovative immunology therapies, addressing unmet needs in patient care amidst the complexity of autoimmune disorders.