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FDA Rejects Accelerated Approval for Donanemab

Regulators say Eli Lilly’s Alzheimer’s drug doesn’t have sufficient data to expedite approval, delaying commercial availability several months.

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According to a recent Reuters article, the FDA rejected Eli Lilly’s application for early approval for their Alzheimer’s drug last Friday. The drug in question, donanemab, is an antibody designed to clear amyloid protein plaques from early Alzheimer’s patients’ brains. In a letter, the FDA noted that the reason is “due to the limited number of patients with at least 12 months of drug exposure data provided in the submission. In the company’s mid-stage trial, patients stopped receiving treatment after amyloid was cleared from the brain, which was around the 6 month mark for 40% of patients.

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