• Eli Lilly's Alzheimer's Drug Donanemab Fails to Get Early FDA Approval

    14 days ago - By Time

    Eli Lilly & Co.'s bid for accelerated approval of its Alzheimer's therapy donanemab was rejected by U.S. 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 a relatively small...
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