FDA Committee Recommends Approval for Eli Lilly's Alzheimer's Drug Donanemab Despite Side Effect Concerns
June 11, 2024
On June 10, 2024, the FDA's Peripheral and Central Nervous System Drugs Advisory Committee recommended FDA approval for Eli Lilly's Alzheimer's drug, Donanemab.
Donanemab is intended for individuals with mild dementia caused by Alzheimer's disease.
The drug aims to slow cognitive decline in early-stage patients by targeting amyloid protein in the brain.
Concerns remain about potential side effects such as brain bleeding and long-term effectiveness.
The committee decided not to restrict the drug based on tau levels.
More research is needed on Donanemab's efficacy in diverse populations and its duration of use.
The FDA's final decision on the drug is expected later this year.
There are hopes that Donanemab's approval will contribute to the development of disease-modifying drugs for Alzheimer's.
Summary based on 9 sources
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Sources
The New York Times • Jun 10, 2024
Leqembi and Alzheimer’s: What to Know About the New Drug, Treatment and Benefits
Nature • Jun 10, 2024
Alzheimer's drug with modest benefits wins backing of FDA advisers