FDA converts Leqembi to traditional approval

The US Food and Drug Administration (FDA) has converted Leqembi (lecanemab-irmb), indicated to treat adult patients with Alzheimer's Disease, to traditional approval following a determination that a confirmatory trial verified clinical benefit.

Leqembi is the first amyloid beta-directed antibody to be converted from an accelerated approval to a traditional approval for the treatment of Alzheimer's disease.

The Eisai (TYO: 4523) and Biogen (Nasdaq: BIIB) drug was approved in January under the Accelerated Approval pathway, a route that allows the FDA to approve drugs for serious conditions where there is an unmet medical need, based on clinical data demonstrating the drug's effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients.