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 European Medicines Agency's CHMP has issued a positive opinion for RINVOQ® (upadacitinib) to treat moderate to severe atopic dermatitis in adults and adolescents. The recommendation is based on data from three Phase 3 studies involving over 2,500 patients, showing significant improvements in skin clearance and itch reduction compared to placebo. The approval would mark RINVOQ as the first JAK inhibitor in the EU for this indication. If approved by the European Commission, RINVOQ will expand its indications, enhancing AbbVie's portfolio in dermatology.
AbbVie (NYSE: ABBV) has announced the acquisition of TeneoOne and its lead asset TNB-383B, a promising immunotherapeutic targeting relapsed or refractory multiple myeloma. This move comes after positive interim results from a Phase 1 study, which reported a 79% objective response rate and a 63% very good partial response rate. The recommended Phase 2 dosing aims for less frequent administration, enhancing patient convenience. The acquisition awaits customary closing conditions, including antitrust clearance.
AbbVie Inc. (NYSE: ABBV) has declared a quarterly cash dividend of $1.30 per share, payable on August 16, 2021, to stockholders of record by July 15, 2021. This dividend reflects AbbVie's strong performance, having increased its dividend by 225% since its founding in 2013. AbbVie is part of the S&P Dividend Aristocrats Index, recognizing companies that have increased dividends annually for over 25 years.
AbbVie announced promising results from the Phase 3 GLOW study evaluating the combination of IMBRUVICA® (ibrutinib) and VENCLEXTA®/VENCLYXTO® (venetoclax) versus chlorambucil plus obinutuzumab in first-line treatment for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The study achieved its primary endpoint, showing a 78% reduction in disease progression risk with I+V. Secondary endpoints indicated higher rates of undetectable minimal residual disease and better complete response rates. The safety profile was consistent with previous treatments, indicating I+V's potential as a new standard therapy.
AbbVie (NYSE: ABBV) reported results from a four-year follow-up of the Phase 3 CLL14 trial, demonstrating that patients with chronic lymphocytic leukemia (CLL) treated with the VENCLYXTO/VENCLEXTA and obinutuzumab combination had significantly improved progression-free survival (PFS) and higher undetectable minimal residual disease (MRD) rates compared to those receiving standard chemoimmunotherapy. The PFS rate at four years for the combination was 74%, while it was 35.4% for the standard treatment. No new safety concerns were reported, affirming the treatment’s effectiveness.
Allergan Aesthetics, part of AbbVie (NYSE: ABBV), is launching a new campaign titled 'See Yourself' for BOTOX® Cosmetic. This initiative highlights the personal stories of diverse patients, promoting transparency and a judgment-free dialogue about aesthetic treatment. The campaign aims to connect with consumers as interest in aesthetic treatments rises post-pandemic. Directed by acclaimed documentarian Errol Morris, the documentary shorts feature real patient experiences. The campaign reflects BOTOX® Cosmetic's commitment to authenticity and inclusivity in personal aesthetic choices.
AbbVie announced promising Phase 2 CAPTIVATE study results for its investigational combination of IMBRUVICA® and VENCLEXTA® to treat previously untreated chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). The combination achieved a complete response (CR) rate of 56% among patients without del(17p), with a 24-month progression-free survival of 95% and overall survival of 98%. Undetectable minimal residual disease was observed in 77% of patients. Safety profiles aligned with known adverse effects, with no new signals identified.
AbbVie announced new long-term data from the Phase 3 RESONATE-2 study evaluating IMBRUVICA (ibrutinib) for chronic lymphocytic leukemia (CLL). Presenting at the ASCO Annual Meeting, results show sustained progression-free survival (PFS) and overall survival (OS) benefits with IMBRUVICA compared to chlorambucil over seven years. The study revealed a 61% PFS rate and 78% OS rate for IMBRUVICA. Additionally, data from the informCLL registry highlighted treatment alignment with NCCN guidelines, stressing the need for prognostic testing in high-risk patients for optimal therapy.
AbbVie (NYSE: ABBV) will present at the Goldman Sachs 42nd Annual Global Healthcare Conference on June 8, 2021. The event will feature key executives including Michael Severino, Robert A. Michael, and Jeffrey R. Stewart, who will participate virtually at 8:40 a.m. Central time.
A live audio webcast will be available on AbbVie's Investor Relations website, with an archived version to follow later that day.
AbbVie aims to deliver innovative medicines across multiple therapeutic areas, enhancing lives and addressing future medical challenges.
AbbVie announced positive top-line results from the Phase 3 FORTIFY study, demonstrating that risankizumab 360 mg achieved significant endoscopic response and clinical remission in adult patients with moderate to severe Crohn's disease after one year. Key results included 47% achieving endoscopic response and 52% achieving clinical remission, compared to only 22% and 41% in the control group, respectively. Risankizumab 180 mg also met co-primary endpoints in the U.S. analysis. No new safety risks were identified, maintaining a consistent safety profile. Full results will be presented at future conferences.