FDA advisory committee meeting delays approval of donanemab
Drug Discovery World
MARCH 8, 2024
The US Food and Drug Administration (FDA) has revealed plans to convene a meeting of the Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) to discuss the Phase III TRAILBLAZER-ALZ 2 trial. The trial evaluated the efficacy and safety of Eli Lilly’s donanemab in early symptomatic Alzheimer’s disease. The FDA has said it hopes to further understand topics related to evaluating the safety and efficacy of donanemab, including the safety results in donanemab-treated patients
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