The U.S. Food and Drug Administration (FDA) has converted the approval status of Leqembi, a novel Alzheimer's disease treatment, from accelerated to traditional approval. This follows a confirmatory trial that verified the drug's clinical benefit. Leqembi, developed by Eisai Inc., is the first amyloid beta-directed antibody to receive such conversion. The drug reduces amyloid plaques in the brain, a key feature of Alzheimer's disease. The approval was initially granted under the Accelerated Approval pathway, which required a confirmatory study post-approval.