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Neuroscience

FDA declines fast-tracking Alzheimer drug

by Shi En Kim
January 29, 2023 | A version of this story appeared in Volume 101, Issue 4

 

The US Food and Drug Administration has rejected Eli Lilly and Company’s accelerated approval application for donanemab, its Alzheimer’s drug candidate. Last year, the company unveiled positive Phase 2 results for the monoclonal antibody, which showed a fast rate of plaque reduction that prompted Lilly to halt dosing in some participants only 6 months into their regimen. But the FDA wanted more 12-month data, and the lack of these full drug exposure results for at least 100 participants was the basis for the agency’s rejection. Lilly plans to file for traditional approval.

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