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 (NYSE: ABBV) announced the publication of the 24-week results from its Phase 3 SELECT-PsA 1 trial evaluating RINVOQ™ (upadacitinib) for active psoriatic arthritis. The trial demonstrated that RINVOQ 15 mg and 30 mg significantly improved clinical outcomes, including ACR20 response and resolution of enthesitis, compared to placebo. The European Commission has approved RINVOQ for psoriatic arthritis, while the U.S. regulatory evaluation is ongoing. The safety profile was comparable to adalimumab, with upper respiratory infections as the most common adverse effect.
AbbVie (NYSE: ABBV) is set to announce its first-quarter 2021 financial results on April 30, 2021, prior to market opening. A live webcast of the earnings conference call will occur at 8 a.m. Central time on the same day, available via AbbVie's Investor Relations website. This announcement showcases AbbVie's commitment to transparency regarding its financial performance and operational updates, emphasizing its ongoing mission to address serious health issues through innovative medicines.
AbbVie (NYSE: ABBV) announced the acceptance of its New Drug Application (NDA) by the FDA for atogepant, an oral CGRP receptor antagonist, aimed at preventing migraine in adults. This decision is expected to lead to a regulatory decision by late Q3 2021. The NDA is backed by clinical data from nearly 2,500 participants, indicating atogepant's effectiveness in reducing migraine days significantly compared to placebo. The pivotal Phase 3 ADVANCE study demonstrated substantial results, with all treatment doses meeting primary efficacy endpoints.
AbbVie (NYSE:ABBV) announced an extension of the FDA review period for its supplemental New Drug Application (sNDA) for upadacitinib in treating adults with active psoriatic arthritis. The PDUFA action date has been pushed back by three months to late Q2 2021 due to an FDA request for further assessment of the drug's benefit-risk profile. Additionally, AbbVie is preparing a similar sNDA for upadacitinib's use in atopic dermatitis. The company remains confident about the approval process and its commitment to patient treatment options.
Allergan, an AbbVie company, submitted a New Drug Application (NDA) to the FDA for AGN-190584, a treatment for presbyopia, affecting 128 million U.S. adults. Expected FDA action is by end of 2021. AGN-190584 showed significant improvement in near vision in clinical studies without compromising distance vision. No serious adverse events were reported, with headache and conjunctival hyperemia as common non-serious side effects. This novel treatment could revolutionize care for presbyopia, offering a non-invasive option for those affected.
AbbVie announced FDA approval for HUMIRA® (adalimumab) to treat moderately to severely active ulcerative colitis in pediatric patients aged 5 and older. This marks the first subcutaneous biologic for these patients, allowing home administration. The approval stems from the Phase 3 ENVISION I study, which demonstrated that HUMIRA induced remission by Week 8 and maintained it at Week 52. This advancement aims to address the significant unmet needs in pediatric ulcerative colitis, providing a new, effective treatment option for children suffering from this chronic condition.
AbbVie has launched REFRESH® DIGITAL, a new lubricant eye drop designed to alleviate dryness and irritation from prolonged screen use, which affects over half of American adults. This product incorporates HydroCell™ technology to support tear film hydration. With Americans averaging 13 hours daily on digital devices, optometrist Dr. Selina McGee emphasizes the importance of this advancement for eye comfort. REFRESH® DIGITAL is available in multidose bottles and preservative-free vials at retail locations nationwide.
AbbVie announced that its drug, upadacitinib (45 mg daily), achieved significant results in the Phase 3 U-ACCOMPLISH study for treating moderate to severe ulcerative colitis. 33% of patients reached clinical remission by week 8, compared to 4% on placebo (p<0.001). All primary and ranked secondary endpoints were met, demonstrating effective clinical response and endoscopic improvements. Common adverse events included acne and increased blood creatine phosphokinase, but no new safety risks were observed. Full results will be shared at a future meeting.
AbbVie (NYSE: ABBV), Evolus (NASDAQ: EOLS), and Medytox have settled all litigation related to Jeuveau®, resolving a case filed by Medytox against Evolus. Under the agreement, AbbVie and Medytox release claims against Evolus and allow the commercialization of Jeuveau® in the U.S. and Nuceiva™ elsewhere. Evolus will pay milestone and royalty fees and issue stock to Medytox. This settlement follows an ITC decision from December 16, 2020, that found misappropriation of Medytox's trade secrets but does not affect ongoing legal matters with Daewoong.
AbbVie (NYSE: ABBV) will participate in the Cowen 41st Annual Health Care Conference on March 3, 2021, at 10:40 a.m. CT. Key executives including Michael Severino, Robert A. Michael, and Jeffrey R. Stewart will present virtually. A live audio webcast will be available on AbbVie's Investor Relations website, with an archived version accessible later the same day.
AbbVie focuses on delivering innovative medicines across multiple therapeutic areas, including immunology, oncology, and neuroscience.