FDA Delays Lilly's Alzheimer's Drug Decision With AdComm Meeting, As Lilly Says Data Back Full CMS Coverage

By Maaisha Osman / March 8, 2024 at 2:23 PM

FDA has unexpectedly delayed its decision on whether to approve Eli Lilly’s high-profile Alzheimer’s drug donanemab by calling for an advisory committee meeting to review the safety and efficacy implications of the drug’s Phase 3 trial, coming as Eli Lilly says the trial results are compelling enough to persuade CMS to offer unrestricted coverage.


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