Questions about a change of primary endpoint, treatment cessation and mortality reporting will be asked by a US Food and Drug Administration (FDA) Advisory Committee (AdCom) convened to discuss Eli Lilly’s Alzheimer’s disease candidate donanemab. The meeting, taking place on 10 June, will investigate several elements of the trial and data submitted by the pharma giant as they look for approval of their Alzheimer’s drug. The company filed for market approval of donanemab following the .
The FDA said it would decide on the drug by the end of 2023. However, in November 2023, the agency announced it needed more time, extending the approval until the end of Q1 2024. As the second approval date loomed, the FDA then .
According to GlobalData analysis, sales of donanemab could hit $5.37bn in 2029, with the global market for Alzheimer’s disease set to be worth $13.7bn across the eight major markets (8MM) (US, France, Germany, Italy, Spain, UK, Japan, and China) by 2030.
GlobalData is the parent company of . What the FDA want to investigate The document released by the agency prior to the meeting states that the FDA will want to . This includes whether the data provides evidence of effectiveness of donanemab for the treatment of Alzheimer’s disease, taking into account the support for effectiveness across the subgroups based on tau PET imaging.
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