FDA Grants Traditional Approval To Leqembi (Lecanemab) For Treatment Of Alzheimer’s Disease

The U.S. Food and Drug Administration (FDA) 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. The approval of Leqembi was granted to Eisai Inc. Medicare coverage for Leqembi is now possible.

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 drug works by reducing amyloid plaques that form in the brain, a defining pathophysiological feature of the disease. Leqembi is intended for people . . .