PFE - Pharma Stock Roundup: FDA Panel Endorses LLY's Donanemab PFE's DMD Therapy Study Fails | Benzinga
This week, an FDA advisory committee unanimously recommended approval of Eli Lilly's (NYSE: LLY) Alzheimer's disease drug, donanemab. Pfizer's (NYSE: PFE) phase III study of investigational gene therapy, fordadistrogene movaparvovec, for ambulatory boys with Duchenne muscular dystrophy failed to meet the primary endpoint as well as key secondary endpoints. The FDA approved AstraZeneca's (NASDAQ: AZN) type-II diabetes (T2D) medicine, Farxiga, for pediatric patients. AbbVie (NYSE: ABBV) announced that it is in-licensing exclusive global rights to a next-generation TL1A antibody for the treatment of inflammatory bowel disease (IBD) from a Chinese biotech.
Recap of the Week's Most Important Stories
FDA Panel Unanimously Endorses Lilly's Donanemab: The FDA's Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) voted 11-0 unanimously recommending approval of Lilly's Alzheimer's disease drug, donanemab. The committee said that data from clinical studies on donanemab demonstrated substantial evidence of efficacy and clinically meaningful slowing of disease progression for early symptomatic Alzheimer's patients. Overall, the committee voted that the benefits of donanemab outweighed the risks despite some safety concerns. Anti-amyloid antibodies like donanemab can cause a brain swelling side effect called amyloid-related imaging abnormalities. However, to Lilly's advantage, the panel said such risks could be addressed by "appropriate labelling and management".
If approved by the FDA, donanemab will face strong competition from Biogen and Japanese partner Eisai's Leqembi, which was granted full approval by the FDA for early Alzheimer's disease in the United States in July 2023.
Pfizer's Duchenne Therapy Study Fails: Pfizer's phase III study, CIFFREO, evaluating its mini-dystrophin gene therapy fordadistrogene movaparvovec for treating ...