Eli Lilly says Alzheimer's drug approval delayed as FDA seeks input from advisers
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Drugmaker Eli Lilly announces that the approval of its Alzheimer’s medication donanemab will be delayed due to a last-minute meeting called by the US Food and Drug Administration (FDA) to review the drug’s safety and efficacy. The FDA plans to convene an advisory committee to discuss the drug’s safety and the design of its key clinical trial. The meeting date has yet to be determined. Donanemab is expected to be the second drug on the market shown to slow the progression of Alzheimer’s disease. Lilly expresses confidence in the drug’s potential benefits.