ABBVIE INC. - ABBV STOCK NEWS

AbbVie announced the publication of 24-week results from the Phase 3b Heads Up study in JAMA Dermatology, showcasing the efficacy of RINVOQ (upadacitinib) over DUPIXENT (dupilumab) in treating moderate to severe atopic dermatitis in adults. At week 16, 71% of RINVOQ patients achieved at least a 75% improvement in eczema severity versus 61% for DUPIXENT. RINVOQ also resulted in faster reductions in itch and skin clearance. Despite a consistent safety profile, serious adverse events were noted, including one treatment-related death. The study will influence clinical treatment strategies for atopic dermatitis.

AbbVie reported strong Q2 2021 results with worldwide net revenues of $13.959 billion, a year-over-year increase of 33.9%. The immunology portfolio contributed $6.120 billion, while Skyrizi and Rinvoq showed significant growth. Adjusted diluted EPS rose to $3.11. AbbVie is raising its full-year EPS guidance to $12.57-$12.62. Recent developments include positive EMA recommendations for Rinvoq and successful Phase 3 trials for both Rinvoq and Skyrizi in various indications. The company also announced a collaboration extension with Calico Life Sciences, committing an additional $500 million.

The FDA has approved a label expansion for BOTOX^®, a product by AbbVie (NYSE: ABBV), allowing treatment of eight additional muscles in adults suffering from upper limb spasticity. This includes muscles in the elbow, forearm, and hand, enhancing therapy options for patients affected by conditions like stroke and multiple sclerosis. The new label also permits ultrasound guidance for muscle localization. While BOTOX^® has shown effectiveness in reducing muscle stiffness, it does not improve functional abilities in cases with fixed contractures.

AbbVie and Calico Life Sciences have extended their collaboration, initially established in 2014, to develop therapies for age-related diseases including neurodegeneration and cancer. The partnership, now set to continue until 2025, allows Calico to handle early research while AbbVie offers support for clinical development. Both companies will invest an additional $500 million each into the collaboration. To date, the partnership has led to over 20 early-stage programs related to immuno-oncology and neurodegeneration, and three targets have progressed to clinical trials.

Allergan, a subsidiary of AbbVie (NYSE: ABBV), announced results from the Phase 3 GEMINI 1 study for AGN-190584, an investigational ophthalmic solution aimed at treating presbyopia. The study showed significant vision improvement without loss of distance vision, with 22.5% of participants achieving a three-line gain in near vision at three hours post-dose. AGN-190584 is under FDA review, expected to act by late 2021. The positive study outcomes highlight AGN-190584's potential as a first-line treatment for presbyopia, a progressive eye condition affecting 128 million Americans.

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.