FDA will take a deeper look into the safety and effectiveness of Lilly experimental Alzheimer's drug
Federal regulators are putting off a decision on Eli Lilly’s potential Alzheimer’s treatment with an unusual request to have an advisory committee examine the drug
By TOM MURPHY and MATTHEW PERRONE
Published - Mar 08, 2024, 11:46 AM ET
Last Updated - Mar 08, 2024, 11:46 AM EST
INDIANAPOLIS (AP) — Federal regulators put off a decision on whether to approve an Eli Lilly Alzheimer’s drug by making an unusual request to have outside advisers look at the treatment.
Lilly had expected the Food and Drug Administration to decide on donanemab's approval by the end of the month. But the drugmaker said Friday that the agency now wants more information about its safety and effectiveness.
No date has been set for the advisory committee meeting.
The FDA often asks committees to review drugs that are first in their class of treatments. Donanemab, if approved, would follow Eisai’s Leqembi, which was approved last year, and Biogen’s Aduhelm.
