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

The FDA is poised to grant full approval for Biogen and Eisai's Leqembi drug, which has been developed as a treatment for Alzheimer's disease. The decision is based on data from the pivotal trial Study 301, which showed consistently favorable results for primary and secondary endpoints. In July 2023, the FDA may grant full approval following a vote by an advisory committee that has been asked to..