FDA declines fast-tracking Alzheimer drug

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.