FDA Reviewers Weigh Safety and Approval Scope for Eli Lilly’s Alzheimer’s Drug

Key questions focus on patient eligibility and balancing benefits with potential risks, including brain swelling and bleeding.

FDA analysis shows no major safety concerns but highlights risks for early-stage Alzheimer's patients.
Approval could be limited to patients with specific PET scan results for tau proteins.
Donanemab shows promise in slowing disease progression, comparable to Leqembi.
Potential side effects include brain swelling and bleeding, monitored through MRIs.
FDA panel's recommendations, though non-binding, are typically followed in final decisions.