An FDA advisory panel voted 11-0 in favor of donanemab as a treatment for early symptomatic Alzheimer’s disease. The committee also agreed unanimously that the benefits of the treatment outweighed the risks. Donanemab, a once-per-month, 30-minute infusion treatment by Eli Lilly & Co., was found effective in treating individuals with mild cognitive impairment and mild dementia. More data is needed from underserved populations and those with conditions like Down syndrome. The FDA convened the advisory committee meeting to discuss safety, efficacy, and dosing regimen of donanemab based on the phase 3 TRAILBLAZER-ALZ 2 study.
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FDA advisory committee backs donanemab for early-stage Alzheimer’s
