News Briefs: FDA Sets Date for Donanemab Panel
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May 09, 2024
The FDA on June 10 will consult a panel of outside experts on donanemab, Eli Lilly & Co.’s Alzheimer’s drug. In the advisory committee hearing, third-party experts in neuroscience and drug development will hear presentations from the FDA and Lilly, then be able to question Lilly and FDA officials on the data behind donanemab’s application for approval. A decision on the drug had been expected earlier this year, but the FDA decided to delay it in order to let the advisory committee hearing take place. However, the advisory committee’s recommendation does not carry any official weight. That was a point of controversy after the FDA in 2021 granted accelerated approval to Biogen Inc. & Eisai’s Co.’s Aduhelm (aducanumab), ignoring near-unanimous disapproval from a similar panel. Several advisers resigned from the advisory panel after the Aduhelm accelerated approval decision. Read more
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