Welcome to our dedicated page for Abbvie news (Ticker: ABBV), a resource for investors and traders seeking the latest updates and insights on Abbvie stock.
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 has submitted applications to the FDA and EMA for SKYRIZI® (risankizumab-rzaa) to treat adults with active psoriatic arthritis. These submissions are based on two pivotal Phase 3 trials, KEEPsAKE-1 and KEEPsAKE-2, demonstrating significant improvements in disease activity and skin clearance at week 24. SKYRIZI, an IL-23 inhibitor, aims to provide effective treatment for patients who have not responded to other therapies. The safety profile remains consistent with previous studies, showing no new risks.
AbbVie (NYSE: ABBV) will showcase new data from its neuroscience portfolio at the virtual 2021 American Academy of Neurology (AAN) Annual Meeting, occurring from April 17-22. A total of 33 abstracts will be presented, including one podium and three oral presentations, focusing on migraine, advanced Parkinson's disease, and spasticity. Highlights include pivotal Phase 3 data on atogepant for migraine prevention and the study of ABBV-951, a continuous infusion treatment for advanced Parkinson's disease. AbbVie aims to make significant impacts on neurological disorders through its innovative treatments.
AbbVie announced an extension of the FDA review period for the supplemental New Drug Application (sNDA) of upadacitinib for moderate to severe atopic dermatitis. The action date has been moved to early Q3 2021, a three-month extension. This request from the FDA was for an updated assessment of the drug's benefit-risk profile, expected due to the complexity of the review process. AbbVie remains optimistic about the application and continues to collaborate with the FDA to expedite the approval process for this important treatment option.
Allergan Aesthetics, part of AbbVie, has launched SkinMedica® Neck Correct Cream to target neck and décolleté aging. This innovative product is designed to firm, tighten, and improve the appearance of moderate to severe neck aging, featuring efficacy in clinical studies with users reporting significant satisfaction. It targets key aging concerns using a blend of peptides, antioxidants, and botanical extracts. Priced at $135, it’s available through licensed physicians and spas, supported by a digital campaign highlighting its performance. For more details, visit SkinMedica.com.
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.