FDA Advisory Committee Recommends approval of new Alzheimer’s drug Donanemab
https://sciencebasedmedicine.org/fda-advisory-committee-recommends-approval-of-new-alzheimers-drug-donanemab/
The FDA advisory panel has recommended the approval of donanemab, a new Alzheimer’s drug by Eli Lilly, after voting unanimously that it effectively slows early-stage Alzheimer’s disease and that its benefits outweigh the risks. Despite this, concerns remain regarding the drug’s efficacy in all populations, side effects like brain swelling and bleeding, and the overall uncertainty surrounding the amyloid hypothesis on which the drug’s premise is based. The FDA is expected to act on the panel’s recommendation in the coming months.