FDA Indicates Potential Full Approval for Eisai & Biogen’s Leqembi Ahead of Adcomm

The FDA is likely to grant full approval for Eisai and Biogen's Leqembi (lecanemab) for the treatment of Alzheimer's disease ahead of an advisory committee vote on the drug. The agency has asked the committee to confirm whether Study 301 results verify lecanemab's clinical benefit, but both the briefing documents and decision will be based on these results. The data from the trial consistently s..