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 FDA approved RINVOQ® (upadacitinib) for treating moderate to severe atopic dermatitis in adults and children aged 12 and older. This approval is significant for patients unresponsive to previous treatments, providing a once-daily oral option. Supported by data from over 2,500 patients in Phase 3 trials, RINVOQ demonstrated strong efficacy, with up to 80% of patients achieving significant skin clearance. However, it carries risks of serious infections and cardiovascular issues. AbbVie aims to improve patient access through support programs.
AbbVie confirms its revenue guidance for 2025, projecting combined risk-adjusted sales exceeding $15 billion from Rinvoq and Skyrizi. The forecast includes more than $7.5 billion in sales for each product. Adjustments were made due to lower sales expectations for Rinvoq in the U.S. after label updates, balanced by increased international sales and higher demand in Crohn's disease and ulcerative colitis, following positive Phase 3 study results. Skyrizi's growth is attributed to strong performance in psoriasis.
On January 11, 2022, ACELYRIN, INC. appointed Melanie Gloria as the new Chief Operating Officer (COO). With over 20 years in biotechnology, Gloria previously held senior roles at Abbott, AbbVie, and Horizon Therapeutics, leading R&D functions and achieving global therapy approvals. Her extensive background in drug development includes multiple therapeutic areas such as oncology and immunology. The leadership team believes Gloria's experience will enhance ACELYRIN's pursuit of life-changing treatments and support its growth strategy.
AbbVie has submitted applications for upadacitinib (RINVOQ®) to the FDA and EMA to treat adults with active non-radiographic axial spondyloarthritis (nr-axSpA) who inadequately respond to NSAIDs. Based on the Phase 3 SELECT-AXIS 2 trial, upadacitinib showed efficacy in reducing symptoms and improving physical function. Additionally, AbbVie requested label enhancements for upadacitinib in the EU for active ankylosing spondylitis (AS). The safety profile remained consistent with previously known data, with no new risks identified.
AbbVie (NYSE: ABBV) is set to report its fourth-quarter and full-year 2021 financial results on February 2, 2022, before market opening. A live webcast of the earnings call will occur at 8 a.m. CT on the same day, accessible via AbbVie's Investor Relations website. Following the event, an archived version will be available for later viewing. AbbVie focuses on delivering innovative medicines across various therapeutic areas including immunology, oncology, and neuroscience.
AbbVie (NYSE: ABBV) has received Breakthrough Therapy Designation (BTD) from the FDA for its investigational drug telisotuzumab vedotin (Teliso-V). This designation targets patients with advanced/metastatic non-small cell lung cancer (NSCLC) characterized by high c-Met overexpression and disease progression post-platinum therapy. Teliso-V aims to address the significant unmet medical needs in NSCLC treatments. Data from the ongoing Phase 2 study (LUMINOSITY) shows promising preliminary efficacy, with an overall response rate of 53.8% among patients with c-Met overexpressing tumors.
AbbVie (NYSE: ABBV) is set to participate in the 40th Annual J.P. Morgan Healthcare Conference on January 11, 2022, at 2:45 p.m. CT. Key executives, including Robert A. Michael, Michael E. Severino, M.D., and Jeffrey R. Stewart, will present virtually. A live audio webcast will be accessible on AbbVie's Investor Relations website, with an archived session available later that day. AbbVie focuses on innovative medicines across various therapeutic areas including immunology and oncology.
On December 16, 2021, Allergan Aesthetics, part of AbbVie (NYSE: ABBV), completed its acquisition of Soliton, Inc. (NASDAQ: SOLY). This acquisition enhances Allergan's offering of non-invasive body contouring solutions by adding the RESONIC™ device, which is FDA-cleared for long-term cellulite improvement and tattoo removal. Clinical data showed that 97.6% of participants reported significant cellulite improvement post-treatment. The acquisition reflects Allergan's commitment to innovation in aesthetic treatments, addressing consumer concerns about cellulite.
AbbVie announced the FDA's approval of RINVOQ (upadacitinib) for treating adults with active psoriatic arthritis (PsA) who are unresponsive or intolerant to TNF blockers. This approval is backed by two Phase 3 trials, SELECT-PsA 1 and SELECT-PsA 2, where RINVOQ met its primary endpoint with ACR20 responses of 71% and 57% vs. placebo. It demonstrated significant improvements in joint efficacy, physical function, and fatigue. Despite its benefits, RINVOQ carries risks of serious infections and cardiovascular events, particularly in older patients with heart disease risk factors.
Allergan, part of AbbVie, announced the availability of VUITY™ (pilocarpine HCl ophthalmic solution) 1.25%, the first FDA-approved eye drop for treating presbyopia, affecting around 128 million Americans. The innovative formulation utilizes proprietary pHast™ technology to enhance near vision while maintaining distance focus. Clinical studies demonstrated significant efficacy, with participants achieving notable improvements in visual acuity.
VUITY is now available by prescription in pharmacies across the U.S., emphasizing AbbVie's commitment to advancing eye care.