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.
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AbbVie Inc. (NYSE: ABBV) has declared a quarterly cash dividend of $1.41 per share, payable on August 15, 2022, for stockholders of record by July 15, 2022. Since its inception in 2013, AbbVie has increased its dividend by over 250% and is part of the S&P Dividend Aristocrats Index, recognized for consistent annual dividend increases for over 25 years. This marks a continued commitment to returning value to shareholders while focusing on innovative therapeutic solutions.
AbbVie has submitted a supplemental New Drug Application (sNDA) for atogepant (QULIPTA) to the FDA, aiming to expand its indication for preventing chronic migraines in adults. This follows the pivotal Phase 3 PROGRESS trial, which demonstrated a statistically significant reduction in mean monthly migraine days compared to placebo. If approved, atogepant will be the first gepant available for chronic migraine treatment, positioning AbbVie as the only company with two preventive treatments for chronic migraines, alongside BOTOX.
Allergan Aesthetics, part of AbbVie, launched 'The Future of Aesthetics' global trends report to help the industry navigate evolving consumer needs. The report, developed with Wunderman Thompson Intelligence, involved extensive research and interviews with leading practitioners. It highlights a surge in dermal filler treatments, growing consumer diversity in aesthetics, and ten major trends expected to shape the industry over the next five years. Carrie Strom emphasized the importance of understanding these trends for future growth and innovation in aesthetics.
AbbVie announced FDA approval for SKYRIZI (risankizumab-rzaa) as the first specific interleukin-23 (IL-23) inhibitor for moderately to severely active Crohn's disease in adults. Supported by data from three clinical trials, SKYRIZI showed significant improvement in clinical response and remission at various intervals. The treatment involves an initial intravenous infusion followed by subcutaneous injections. This approval marks a significant advancement in options for Crohn's disease patients, which affects daily life due to unpredictable symptoms.
AbbVie reports positive results from the EPCORE NHL-1 phase 2 trial of epcoritamab for relapsed/refractory large B-cell lymphoma (LBCL). The study showed an overall response rate (ORR) of 63% with a complete response (CR) of 39%. Notably, CAR T-naïve patients had a 69% ORR and 42% CR. The safety profile was consistent with prior data, with most adverse effects occurring in the initial treatment phase. These findings were presented at the EHA's Presidential Symposium, highlighting a significant advancement in treatment options for LBCL.
AbbVie announced preliminary data from the Phase 2 REFINE study, showing positive early results for navitoclax combined with ruxolitinib in treating JAK inhibitor naïve myelofibrosis (MF) patients. Data revealed a 63% spleen volume reduction of ≥35% at week 24. Additionally, 41% of evaluable patients reported a ≥50% reduction in symptom scores. No new safety signals were identified, though 97% of patients reported adverse events, with thrombocytopenia being the most common. These findings could support further exploration of navitoclax as a treatment to modify disease progression.
AbbVie announced five-year follow-up results from the Phase 3 CLL14 trial, revealing that over 60% of patients with untreated chronic lymphocytic leukemia (CLL) who received a one-year treatment of venetoclax plus obinutuzumab maintained longer progression-free survival (PFS) compared to those treated with chlorambucil plus obinutuzumab. The median PFS was not reached for the venetoclax group versus 36.4 months for the chlorambucil group (p0.0001). Moreover, 18.1% of patients treated with venetoclax showed undetectable minimal residual disease after four years, demonstrating the regimen's effectiveness in CLL treatment.
AbbVie announced it will showcase data from its migraine portfolio at the 2022 AHS Annual Scientific Meeting in Denver, June 9-12. The highlights include findings from the Phase 3 PROGRESS trial for atogepant (QULIPTA) in preventing chronic migraine. This research may support a supplemental New Drug Application with the FDA to expand atogepant’s indication. AbbVie will also present data on ubrogepant (UBRELVY) and onabotulinumtoxinA (BOTOX), enhancing its commitment to treating migraine sufferers. A total of 29 abstracts will provide insights into ongoing research in migraine therapies.
AbbVie announced positive outcomes from the Phase 3 SELECT-AXIS 2 trials of upadacitinib (RINVOQ) aimed at treating non-radiographic axial spondyloarthritis (nr-axSpA) and ankylosing spondylitis (AS) in patients with inadequate responses to existing therapies. Both studies met the primary endpoint, achieving the ASAS40 response at week 14—45% for nr-axSpA compared to 23% placebo, and 45% for AS compared to 18% placebo. Safety profiles remained consistent with previous studies, with no new risks identified. Regulatory applications to the FDA and EMA for nr-axSpA are ongoing.