Abbvie Inc Stock Price, News & Analysis

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 (p<0.0001). 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 (p<0.0001). 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.

AbbVie has shared new Phase 3 data analyses from the KEEPsAKE-1 and KEEPsAKE-2 studies, detailing the efficacy of risankizumab (SKYRIZI^®) in treating adults with active psoriatic arthritis over one year. At the 2021 EADV Virtual Congress, results showed significant patient responses, with 70% and 58% achieving ACR20 response in KEEPsAKE-1 and KEEPsAKE-2, respectively. Furthermore, 76% achieved resolution of dactylitis. The safety profile remained consistent, with no new adverse findings reported. These developments underscore AbbVie's commitment to enhancing treatment options for psoriatic arthritis.

AbbVie (NYSE: ABBV) presented new analyses of its medication RINVOQ® (upadacitinib) for treating moderate to severe atopic dermatitis at the EADV Virtual Congress. Key findings include that over 61% of patients on RINVOQ 30 mg achieved EASI 75 at week 16 compared to 11% on placebo, irrespective of demographics. Additionally, RINVOQ demonstrated superior efficacy against dupilumab in four body regions at week 16. The safety profile remained consistent with previous studies, with acne as the most common adverse event.

AbbVie (NYSE: ABBV) announced FDA approval for QULIPTA™ (atogepant), the first oral CGRP receptor antagonist for preventing episodic migraines in adults. Supported by robust clinical data, QULIPTA demonstrated significant reductions in monthly migraine days and was well tolerated among nearly 2,000 patients in trials. It aims to alleviate the substantial disability caused by migraines, which affect over 39 million people in the U.S. QULIPTA will be available in October 2021, complementing AbbVie's migraine treatment portfolio.