Abbvie Inc Stock Price, News & Analysis

AbbVie announced FDA approval for DALVANCE (dalbavancin) to treat acute bacterial skin and skin structure infections (ABSSSI) in pediatric patients. This is the first single-dose intravenous treatment for ABSSSI caused by susceptible Gram-positive bacteria in children, including MRSA. The approval is based on a clinical trial demonstrating a 97.3% early clinical response rate for the single-dose regimen. DALVANCE shows bactericidal activity against various Gram-positive bacteria. In the U.S., ABSSSI accounts for 3 million pediatric healthcare visits annually, indicating significant market potential.

AbbVie announced that the FDA granted a Breakthrough Therapy Designation to venetoclax (VENCLEXTA) in combination with azacitidine for treating adults with untreated intermediate- to very high-risk myelodysplastic syndromes (MDS). This designation accelerates the development of promising therapies for serious conditions and is based on preliminary clinical data. MDS affects around 10,000 patients annually in the U.S., with a substantial risk of progression to acute myeloid leukemia. This marks the sixth designation for venetoclax, showcasing its potential in treating blood cancers.

Allergan, part of AbbVie (NYSE: ABBV), will present new eye care data at the 2021 ASCRS Annual Meeting from July 23-27 in Las Vegas. Key highlights include results on AGN-190584, an investigational presbyopia treatment, and DURYSTA™, the first FDA-approved dissolvable implant for glaucoma management. Data from the Phase 3 GEMINI 1 study on AGN-190584 and the ARTEMIS studies on DURYSTA will be shared, enhancing understanding of these innovative treatments. FDA action on AGN-190584's NDA is anticipated by year-end 2021.

AbbVie announced that the FDA did not meet the action date for the supplemental New Drug Application for RINVOQ (upadacitinib) aimed at treating moderate to severe atopic dermatitis. The FDA's delay is linked to its ongoing review of a Pfizer study. No formal regulatory actions have been taken regarding RINVOQ for atopic dermatitis, psoriatic arthritis, or ankylosing spondylitis. AbbVie remains confident in RINVOQ's efficacy and safety, continuing collaboration with the FDA to facilitate patient access.

AbbVie (NYSE: ABBV) will release its second-quarter 2021 financial results on July 30, 2021, before market opening. A live webcast of the earnings conference call will be available at 8 a.m. Central time on the company's Investor Relations website. An archived session will be accessible later that day. AbbVie aims to develop innovative medicines across various therapeutic areas, including immunology, oncology, and neuroscience. For more details, visit www.abbvie.com.

AbbVie announced that upadacitinib successfully met its primary and secondary endpoints in a Phase 3 study for ulcerative colitis. At week 52, clinical remission rates for 15 mg and 30 mg doses were 42% and 52%, respectively, compared to 12% for placebo (p<0.001). Additionally, significant improvements were noted in endoscopic measures and corticosteroid-free remission. The safety profile remained consistent with prior studies, with no new risks identified. Positive results have potential implications for treatment options in moderate to severe ulcerative colitis.

AbbVie announced that new data on upadacitinib for ulcerative colitis and risankizumab for Crohn's disease will be presented at the 16th Congress of ECCO on July 2-3 and July 8-10. The company will share nine abstracts, including five oral presentations, focusing on inflammatory bowel diseases (IBD). Key findings from pivotal Phase 3 studies for both drugs will be highlighted, showcasing efficacy, safety, and patient-reported outcomes. AbbVie aims to enhance understanding of patient preferences and improve standards of care in gastrointestinal diseases.

AbbVie announced that the U.S. FDA will not meet the Prescription Drug User Fee Act (PDUFA) action dates for the supplemental New Drug Applications (sNDAs) for RINVOQ® (upadacitinib) targeting psoriatic arthritis and ankylosing spondylitis due to ongoing reviews related to a post-marketing study of a competitor's drug. No formal regulatory action has been taken yet. Despite this setback, AbbVie remains committed to collaborating with the FDA to deliver RINVOQ to patients.

AbbVie announced that the European Medicines Agency's CHMP has issued a positive opinion for RINVOQ^® (upadacitinib) to treat moderate to severe atopic dermatitis in adults and adolescents. The recommendation is based on data from three Phase 3 studies involving over 2,500 patients, showing significant improvements in skin clearance and itch reduction compared to placebo. The approval would mark RINVOQ as the first JAK inhibitor in the EU for this indication. If approved by the European Commission, RINVOQ will expand its indications, enhancing AbbVie's portfolio in dermatology.