News Briefs: Lilly Alzheimer’s Drug Fails to Win Accelerated Approval

The FDA declined to grant accelerated approval for Alzheimer’s disease treatment donanemab and requested additional data from its manufacturer, Eli Lilly & Co. said on Jan. 19. The move comes on the heels of the FDA’s decision to bestow accelerated approval on another Alzheimer’s treatment called Leqembi (lecanemab) from Biogen and Eisai — although a National Coverage Determination issued for Biogen’s Aduhelm (aducanumab) significantly limits who can access any drug in that class that receives accelerated approval. In its response letter to Lilly, the FDA cited “the limited number of patients with at least 12 months of drug exposure data provided in the submission” for accelerated approval as its justification for denying the application, and the agency asked Lilly to provide data from at least 100 patients who received a minimum of 12 months of continued treatment on donanemab. Lilly said it expects to unveil results from its Phase III confirmatory trial in the second quarter of this year, and that “will form the basis of donanemab’s application for traditional approval shortly thereafter.”

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