FDA will take a deeper look into the safety and effectiveness of Lilly experimental Alzheimer’s drug

By TOM MURPHY and MATTHEW PERRONE
Associated Press

INDIANAPOLIS (AP) — 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. Lilly expected a decision on donanemab in this year’s first quarter, which ends this month. But the drugmaker said Friday that the Food and Drug Administration wants more information about donanemab’s 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.