The FDA plans a meeting with advisors to review Eli Lilly's Alzheimer's drug donanemab's safety and efficacy before approval.
Eli Lilly's experimental Alzheimer's drug, donanemab, has faced a delay in its approval process as the US Food and Drug Administration (FDA) plans to hold a meeting with external advisors to review the drug's safety and efficacy. If approved, donanemab would be the second drug to slow the progression of Alzheimer's disease, following Eisai and Biogen's Leqembi. Both medications target amyloid plaque buildup in the brain. The FDA is set to discuss the safety of donanemab and the design of a key clinical trial, Trailblazer-Alz 2, but no meeting date has been set yet.
March 08, 2024
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