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 has shared new Phase 3 data analyses from the KEEPsAKE-1 and KEEPsAKE-2 studies, detailing the efficacy of risankizumab (SKYRIZI®) in treating adults with active psoriatic arthritis over one year. At the 2021 EADV Virtual Congress, results showed significant patient responses, with 70% and 58% achieving ACR20 response in KEEPsAKE-1 and KEEPsAKE-2, respectively. Furthermore, 76% achieved resolution of dactylitis. The safety profile remained consistent, with no new adverse findings reported. These developments underscore AbbVie's commitment to enhancing treatment options for psoriatic arthritis.
AbbVie (NYSE: ABBV) presented new analyses of its medication RINVOQ® (upadacitinib) for treating moderate to severe atopic dermatitis at the EADV Virtual Congress. Key findings include that over 61% of patients on RINVOQ 30 mg achieved EASI 75 at week 16 compared to 11% on placebo, irrespective of demographics. Additionally, RINVOQ demonstrated superior efficacy against dupilumab in four body regions at week 16. The safety profile remained consistent with previous studies, with acne as the most common adverse event.
AbbVie (NYSE: ABBV) announced FDA approval for QULIPTA™ (atogepant), the first oral CGRP receptor antagonist for preventing episodic migraines in adults. Supported by robust clinical data, QULIPTA demonstrated significant reductions in monthly migraine days and was well tolerated among nearly 2,000 patients in trials. It aims to alleviate the substantial disability caused by migraines, which affect over 39 million people in the U.S. QULIPTA will be available in October 2021, complementing AbbVie's migraine treatment portfolio.
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AbbVie (NYSE: ABBV) announced it will present 27 abstracts at the 30th EADV Congress from September 29 to October 2, 2021. Highlights include analyses on RINVOQ (upadacitinib) for atopic dermatitis and new data on SKYRIZI (risankizumab) for psoriasis and psoriatic arthritis. Key findings will come from Phase 3 trials, including a head-to-head study of RINVOQ vs. dupilumab, showcasing safety and efficacy. This reinforces AbbVie's commitment to enhancing care for chronic inflammatory diseases.
AbbVie announced the submission of an application to the FDA for risankizumab-rzaa, a new treatment for moderate to severe Crohn's disease in patients aged 16 and older. This drug, an IL-23 inhibitor, is backed by data from three Phase 3 trials: ADVANCE, MOTIVATE, and FORTIFY. In these studies, patients treated with risankizumab-rzaa showed significantly greater clinical remission and endoscopic response compared to placebo. The therapy aims to address the unmet need for lasting remission in Crohn's patients, as highlighted by AbbVie’s senior VP of research.
AbbVie has submitted applications to the FDA and EMA for upadacitinib (15 mg, 30 mg, and 45 mg) for treating adults with moderately to severely active ulcerative colitis. These submissions are based on positive results from two Phase 3 induction studies and one maintenance study, where upadacitinib showed significant improvement in clinical remission compared to placebo. Additionally, the safety profile was consistent with existing data, with no new risks identified. This treatment could provide a new option for patients who have not responded adequately to current therapies.
AbbVie and REGENXBIO announced a partnership to develop RGX-314, a gene therapy for wet age-related macular degeneration (AMD) and diabetic retinopathy (DR). REGENXBIO will complete ongoing trials, while AbbVie leads global development and commercialization. AbbVie will pay REGENXBIO $370 million upfront, with potential total payments of up to $1.38 billion based on milestones. They will share profits from U.S. sales equally, with AbbVie paying tiered royalties internationally. The deal is expected to close by the end of 2021, contingent on regulatory approvals.
AbbVie Inc. (NYSE: ABBV) has declared a quarterly cash dividend of $1.30 per share, payable on November 15, 2021, to stockholders of record by October 15, 2021. Since its inception in 2013, AbbVie has increased its dividend by 225% and is recognized as a member of the S&P Dividend Aristocrats Index, highlighting its commitment to consistent annual dividend increases over at least 25 consecutive years.
AbbVie (NYSE: ABBV) will showcase over 20 abstracts from its neuroscience portfolio at the MDS Virtual Congress 2021, scheduled for September 17-22. This includes long-term data on DUODOPA® for advanced Parkinson's disease and BOTOX® for spasticity and cervical dystonia. The research aims to address unmet needs in movement disorders, enhancing standards of care. The data will be accessible as virtual e-posters starting September 10, with a focus on real-world effectiveness and comparative studies related to patient outcomes.