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.
Allergan, a subsidiary of AbbVie (NYSE: ABBV), announced the presentation of new data on its eye care treatments at the 2022 American Glaucoma Society (AGS) Annual Meeting from March 3-6 in Nashville, TN. Key presentations will focus on DURYSTA® (bimatoprost intracameral implant) and XEN® Gel Stent, highlighting findings two years post-FDA approval of DURYSTA. Research includes studies on efficacy, safety, and real-world effectiveness of these treatments, aiming to enhance outcomes for glaucoma patients.
AbbVie announced promising top-line results from the U-EXCEL Phase 3 study, revealing that upadacitinib (45 mg daily) met its primary endpoints for clinical remission and endoscopic response in adults with moderate to severe Crohn's disease. At week 12, 49% of patients achieved clinical remission versus 29% on placebo (p0.0001), and 46% achieved endoscopic response compared to 13% on placebo (p<0.0001). The safety profile was consistent with previous studies, with no new risks identified. Full results are to be presented in medical conferences and published in peer-reviewed journals.
AbbVie has submitted a supplemental New Drug Application (sNDA) for cariprazine (VRAYLAR) to the FDA for treating major depressive disorder (MDD) as an adjunct therapy with ongoing antidepressants. The submission is backed by Phase 3 studies indicating significant improvement in depression scores. Two studies, 3111-301-001 and RGH-MD-75, demonstrated substantial changes in the Montgomery-Åsberg Depression Rating Scale after treatment. Safety profiles remained consistent with previous data, supporting the potential for addressing treatment gaps for patients with MDD.
The board of directors of AbbVie declared a quarterly cash dividend of $1.41 per share, payable on May 16, 2022. Stockholders of record by April 15, 2022 will receive this dividend. Since its inception in 2013, AbbVie has increased its dividend by over 250%, making it a member of the S&P Dividend Aristocrats Index, which includes companies with at least 25 consecutive years of annual dividend increases.
Healis Therapeutics has secured ownership of a crucial botulinum toxin patent from AbbVie (NYSE: ABBV). This license transfer allows Healis to develop this treatment for Major Depressive Disorder (MDD), following successful results in eight Phase II trials. The acquisition is poised to expedite Healis' mission in the neuromuscular therapeutics space. However, it's important to note that, as of February 2022, botulinum toxin is still not FDA approved for MDD and remains under investigational use only.
Allergan Aesthetics, a subsidiary of AbbVie, announced the FDA's approval of JUVÉDERM® VOLBELLA® XC for improving infraorbital hollows in adults over 21. Clinical data indicates a high satisfaction rate, with 90% of patients content one year post-treatment. This new indication enhances Allergan's aesthetic portfolio, addressing significant patient needs. A training program for providers to ensure safe injection practices is mandatory. The product's characteristics aim to offer a smoother, effective solution for undereye treatments. JUVÉDERM® VOLBELLA® XC previously received FDA approval in 2016.
AbbVie announced robust financial results for Q4 2021, reporting worldwide net revenues of $14.886 billion, a 7.4% increase year-over-year. The immunology portfolio contributed $6.746 billion, while Humira's revenue reached $5.334 billion, showing a modest 3.5% rise. The company confirmed guidance of over $15 billion in combined sales for Skyrizi and Rinvoq by 2025. Notable FDA approvals for Rinvoq and Skyrizi expand treatment options, enhancing long-term growth prospects. Full-year 2022 EPS guidance is set between $9.26 and $9.46.
AbbVie (NYSE: ABBV) will showcase its IBD portfolio at the 17th Congress of ECCO from February 16-19, presenting 26 abstracts, including 8 oral and 10 poster presentations. These will focus on HUMIRA® and investigational treatments like risankizumab (SKYRIZI®) and upadacitinib (RINVOQ®). Key analyses include the efficacy of risankizumab in Crohn's disease and the rapid symptom relief of ulcerative colitis with upadacitinib. AbbVie emphasizes its commitment to improve care for IBD patients through ongoing research and development.
Allergan Aesthetics, a subsidiary of AbbVie (NYSE: ABBV), announced an open casting call for individuals to share their personal BOTOX® Cosmetic stories. This initiative supports their ongoing 'See Yourself' campaign aimed at fostering an authentic dialogue regarding aesthetic treatments. The casting call is open until March 2022, with a goal to reach even more consumers than the nearly one billion reached in 2021. Finalists will participate in a nationwide advertising campaign across various digital platforms.
AbbVie announced the FDA approval of SKYRIZI (risankizumab-rzaa) for treating adults with active psoriatic arthritis (PsA). This approval follows data from pivotal studies, KEEPsAKE-1 and KEEPsAKE-2, showing significant efficacy compared to placebo in joint pain and other symptoms. SKYRIZI features a convenient dosing regimen of one injection every three months after initial doses. It aims to alleviate both skin and joint symptoms, improving quality of life for approximately 30% of psoriasis patients who experience PsA.