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Lilly’s Donanemab Fails to Get Early Approval in Alzheimer’s (2)

Jan. 20, 2023, 3:04 PM

Eli Lilly & Co.’s bid for accelerated approval of its Alzheimer’s therapy donanemab was rejected by US regulators, an unexpected setback for the drugmaker.

The Food and Drug Administration sent the company a complete response letter saying it would not give the early approval for the drug because not enough patients on the trial had received it for a full 12 months, Lilly said Thursday in a statement.

The agency wanted Lilly to provide safety data on at least 100 patients who had been on the drug for a year. Lilly’s application for accelerated approval was based on ...