Eli Lilly will face questions from a panel of Alzheimer’s experts on June 10, setting up an approval decision for donanemab after a surprise delay by the FDA in early March.
The drug will go before the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee, the company said in a statement Tuesday. Lilly has previously said that the FDA is especially interested in donanemab’s safety, the company’s proposal to stop treatment once the drug clears up amyloid plaques, and analyses that suggest levels of the brain protein tau can predict how well a person responds to treatment.
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