FDA Converts Novel Alzheimer’s Disease Treatment to Traditional Approval

On July 6, the U.S. Food and Drug Administration (FDA) converted Leqembi (lecanemab), indicated to treat adult patients with Alzheimer's Disease, to traditional approval following a determination that a confirmatory trial verified clinical benefit. Leqembi, developed by Biogen and Eisai, was approved in January 2023 under the Accelerated Approval pathway...