FDA Delays Approval of Eli Lilly's Alzheimer's Drug Donanemab

The unexpected decision to convene an advisory panel for further review comes as the drug showed promise in slowing cognitive decline but raised safety concerns.

FDA delays approval of Eli Lilly's Alzheimer's drug donanemab, requiring further scrutiny by an advisory panel.
The decision to convene an advisory committee was unexpected, as approval was anticipated by the end of March 2024.
Donanemab has shown to slow cognitive decline in Alzheimer's patients by 22% to 35% compared to placebo in clinical trials.
Serious side effects, including brain swelling and bleeding, have been identified, raising concerns about the drug's safety.
The delay reflects the FDA's cautious approach to new Alzheimer's treatments, following controversy over previous drug approvals.