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 presented late-breaking data at the EADV Virtual Congress demonstrating that its drug, upadacitinib, significantly improves skin clearance and reduces itch in atopic dermatitis patients when compared to placebo. In Phase 3 studies, EASI 90 improvement was observed in 53-66% of patients at week 16 versus only 5-8% in the placebo group (p<0.001). Significant itch reduction was also noted. These findings support FDA and EMA approval applications for treating moderate to severe atopic dermatitis. No new safety risks were identified during the trials.
AbbVie (NYSE: ABBV) announced new data presentations for its drugs RINVOQ (upadacitinib) and HUMIRA (adalimumab) at the upcoming ACR Convergence 2020, taking place from November 5-9. A total of 38 abstracts will be showcased, covering various studies in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. Key findings include 84-week and 72-week data on RINVOQ's efficacy and safety as a monotherapy and in comparison to HUMIRA. Presentations will also highlight patient-reported outcomes and long-term safety data for RINVOQ in treating these conditions.
Allergan, a subsidiary of AbbVie (NYSE: ABBV), announced that the Phase 3 GEMINI 1 and 2 clinical trials for AGN-190584 (pilocarpine 1.25%) successfully met their primary endpoints, demonstrating significant improvement in vision for presbyopia patients. The studies involved 750 participants who received the treatment daily for 30 days. Results indicated a notable increase in near vision without compromising distance vision. The company plans to submit a New Drug Application to the FDA in the first half of 2021.
AbbVie announced the submission of applications to the FDA and EMA for RINVOQ™ (upadacitinib), targeting treatment for adults and adolescents with moderate to severe atopic dermatitis. These applications are backed by data from three pivotal Phase 3 studies, demonstrating significant improvement in skin clearance and itch reduction compared to placebo. The co-primary endpoints were met, indicating promising efficacy. The safety profile remains consistent with previous indications, posing no new risks. This submission represents an important step in addressing the unmet needs of patients suffering from this debilitating condition.
AbbVie announced the commencement of its Registered Exchange Offers to exchange existing senior unsecured notes for registered notes. The offers include $30 billion of 2019 USD Notes, $13.25 billion of 2020 USD Notes, and €2.52 billion of Euro Notes. This initiative aims to satisfy obligations under registration rights agreements from prior bond issues related to AbbVie's acquisition of Allergan. The exchange does not represent a new financing transaction and will ensure improved liquidity for investors.
AbbVie has received full FDA approval for VENCLEXTA® (venetoclax) in combination with azacitidine, decitabine, or low-dose cytarabine for treating newly-diagnosed acute myeloid leukemia (AML) in adults over 75 or those unable to receive intensive chemotherapy. This follows accelerated approval in 2018. The Phase 3 VIALE-A trial revealed a 34% reduction in death risk for patients using VENCLEXTA plus azacitidine, with a median overall survival of 14.7 months versus 9.6 months with placebo. However, the VIALE-C trial did not meet its primary endpoint for OS improvement.
Allergan Aesthetics, a subsidiary of AbbVie (NYSE: ABBV), will present four abstracts at the virtual American Society for Dermatologic Surgery (ASDS) meeting from October 9-11, 2020. Key presentations include:
- Patient Satisfaction Following Chin Augmentation With Hyaluronic Acid Fillers, presented by Joely Kaufman on October 10 at 11:27 a.m..
- Treatment of Upper Facial Lines With OnabotulinumtoxinA, presented by Joel L. Cohen on October 11 at 10:27 a.m..
The abstracts will focus on safety, efficacy, and patient satisfaction related to aesthetic treatments.
Allergan Aesthetics, a subsidiary of AbbVie (NYSE: ABBV), has announced its agreement to acquire Luminera, an Israel-based aesthetics company specializing in dermal fillers. This acquisition will enhance Allergan's existing JUV DERM® filler portfolio with Luminera's innovative products, including the differentiated HArmonyCa filler. The deal aims to strengthen Allergan Aesthetics' position in the global aesthetics market, providing new offerings for healthcare professionals and patients. The full dermal filler portfolio will also support international development opportunities.
AbbVie will announce its third-quarter 2020 financial results on October 30, 2020, before market opening. A live webcast of the earnings conference call is scheduled for 8 a.m. Central time. The event can be accessed through AbbVie's Investor Relations website, with an archived version available later that day. AbbVie is dedicated to developing innovative medicines for serious health issues in various therapeutic areas.
AbbVie (NYSE: ABBV) announced its participation at the 2020 Virtual Migraine Trust International Symposium from October 3-9, showcasing findings from 15 clinical trials. Key highlights include new data from the Phase 3 ADVANCE trial for atogepant, a CGRP receptor antagonist aimed at migraine prevention. The symposium will feature oral presentations on October 7, outlining atogepant’s efficacy and safety, as well as research on BOTOX® and UBRELVY®. The ongoing efforts reflect AbbVie's commitment to advancing migraine treatment amid a significant global health burden affecting over 1 billion individuals.