Safety Concerns Remain Ahead Of FDA Ad Comm On Donanemab

By Maaisha Osman, Jessica Karins / June 7, 2024 at 5:38 PM
FDA is widely expected to approve Eli Lilly’s Alzheimer’s drug donanemab following a meeting of its Peripheral and Central Nervous System Drug Advisory Committee meeting Monday (June 10). But some scientists are warning that Lilly’s trial data of the drug is incomplete, and FDA would be relying on the company to make safety and efficacy decisions on the drug. In a briefing document posted online Thursday (June 6), FDA said brain bleeding, infusion-related reactions and hypersensitivity remain significant safety concerns...

Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, FDA news and much more.