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 results from two Phase 3 trials of cariprazine (VRAYLAR) as an adjunctive treatment for major depressive disorder (MDD). In Study 3111-301-001, patients on 1.5 mg/day of cariprazine showed significant improvement in their MADRS scores compared to placebo (p=0.0050). However, 3.0 mg/day did not reach significance. Study 3111-302-001 did not meet its primary endpoint. Positive findings from a prior Phase 2/3 study prompted AbbVie to plan an sNDA with the FDA for expanded cariprazine use. Safety data aligned with established profiles, with common side effects including akathisia and nausea.
AbbVie (NYSE:ABBV) reported robust financial results for Q3 2021, with worldwide net revenues reaching $14.342 billion, an increase of 11.2% year-over-year. The company raised its full-year 2021 EPS guidance to between $6.29 and $6.33. AbbVie also announced a dividend increase of 8.5%, reflecting a 250% increase since inception. Key contributors included strong sales from its immunology portfolio, particularly Humira and Skyrizi. Notable approvals and submissions for new treatments further bolster its long-term growth prospects.
AbbVie announced that ABBV-951 (foslevodopa/foscarbidopa) outperformed oral levodopa/carbidopa in a Phase 3 trial for advanced Parkinson's disease. After 12 weeks, patients receiving ABBV-951 experienced an increase in "On" time without troublesome dyskinesia of 2.72 hours, compared to 0.97 hours for oral LD/CD (p=0.0083). The trial met its primary endpoint, demonstrating a significant reduction in "Off" time as well. While most adverse events were mild, discontinuation due to adverse events was notably higher in the ABBV-951 group (21.6%) versus the oral group (1.5%).
Allergan, an AbbVie company, announced it will present new analyses from Phase 3 trials of AGN-190584 (pilocarpine HCl ophthalmic solution 1.25%) at Academy 2021 from November 3-6. The treatment aims to improve near vision for those with presbyopia, a common age-related condition. Dr. Michael R. Robinson highlighted the significance of these results for practitioners. Phase 3 studies demonstrated significant improvements in near vision without compromising distance vision. ABBV submitted a New Drug Application to the FDA earlier in the year, anticipating market launch as VUITY™.
AbbVie (NYSE: ABBV) announced a positive opinion from the European Medicines Agency's CHMP recommending approval of risankizumab (SKYRIZI®) for treating active psoriatic arthritis in adults with inadequate response to DMARDs. Supported by Phase 3 studies KEEPsAKE-1 and KEEPsAKE-2, the drug demonstrated significant efficacy at week 24. If approved, this will be risankizumab's second indication in the EU, following its 2019 approval for plaque psoriasis. The drug's safety profile remains consistent through 52 weeks of exposure, with common adverse reactions including upper respiratory infections and fatigue.
Allergan Aesthetics, part of AbbVie (NYSE: ABBV), is intensifying its commitment to breast cancer awareness through a series of initiatives under the campaign The Power of You, starting in October and continuing into 2022. Key actions include a limited edition apparel collection with GOLDSHEEP, a virtual fundraiser, a book launch highlighting breast reconstruction, and a film addressing the BRCA1 mutation. Allergan Aesthetics aims to empower women and educate them on breast health, contributing financially to various breast cancer organizations through these programs.
AbbVie announced positive top-line results from the Phase 3 SELECT-AXIS 2 trial evaluating upadacitinib (RINVOQ) for adults with non-radiographic axial spondyloarthritis. The drug achieved the primary ASAS40 endpoint with 45% of patients responding compared to 23% on placebo (p0.0001). Significant improvements were also seen in secondary endpoints, including ASDAS Low Disease Activity (42% vs. 18%, p<0.0001). The safety profile was consistent with previous studies, with common adverse events including headache and COVID-19.
AbbVie announced positive top-line results from the Phase 3 SELECT-AXIS 2 trial for RINVOQ (upadacitinib) in patients with active ankylosing spondylitis who had inadequate responses to previous treatments. The study met its primary endpoint with 45% of patients achieving ASAS40 response at week 14 compared to 18% in the placebo group (p0.0001). Further, RINVOQ demonstrated significant improvements in disease activity and physical functions, with notable reductions in back pain. Safety data were consistent with prior studies, showing no new risks identified.
AbbVie (NYSE: ABBV) is set to release its third-quarter 2021 financial results on October 29, 2021, before market opening. A live webcast of the earnings conference call will occur at 8 a.m. Central time, accessible via AbbVie's Investor Relations website. An archived version will also be available later that day. AbbVie focuses on delivering innovative medicines across various therapeutic areas, including immunology, oncology, and more.
AbbVie announced significant findings on its investigational drugs at the UEG Week Virtual 2021, running from October 3-5. The company will present 13 abstracts, including late-breaking studies on risankizumab (SKYRIZI) for Crohn's disease and upadacitinib (RINVOQ) for ulcerative colitis. Key results from pivotal Phase 3 studies showed upadacitinib's efficacy in symptom control and clinical remission at week 52. Additionally, data highlighting the quality of life improvements for IBD patients will be shared. AbbVie aims to enhance treatment standards in IBD management.