Advisory Board June 11, 2024
An FDA advisory panel voted 11-0 on Monday to recommend the approval of donanemab, a drug developed by Eli Lilly to treat early Alzheimer’s disease, ruling that the drug’s ability to slow cognitive decline in patients outweighed its safety risks.
Top drivers of change in the neurodegenerative disease market
Background
Donanemab is a monoclonal antibody that targets and breaks up amyloid beta plaques, which build up in the brain as Alzheimer’s worsens over time. Although the medication is not a cure for the disease, it can slow its progression.
In a Phase 3 clinical trial, Eli Lilly enrolled 1,736 patients with early symptoms of Alzheimer’s, as well as signs of both amyloid and tau. The patients were stratified by their...
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