Hill March 8, 2024
The Food and Drug Administration (FDA) is delaying approval of a new Alzheimer’s drug from Eli Lilly, and it instead will require the company to face an advisory panel to scrutinize its safety and effectiveness data, the company said Friday.
“The FDA has informed Lilly it wants to further understand topics related to evaluating the safety and efficacy of donanemab, including the safety results in donanemab-treated patients and the efficacy implications of the unique trial design,” Lilly said in a statement.
FDA’s decision came as a surprise to the company. Lilly submitted its traditional approval application of donanemab to the FDA last year and anticipated getting the green light by early 2024.
FDA hasn’t yet set a...
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