FDA approves Alzheimer's disease treatment

Abstract

The U.S. Food and Drug Administration (FDA) on July 6 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, an FDA news released announced. 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 was approved in January under the FDA's Accelerated Approval pathway. This pathway 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 — in the case of Leqembi, reducing amyloid plaques in the brain — that is reasonably likely to predict a clinical benefit to patients. As a post‐marketing requirement of the accelerated approval, the FDA required the applicant to conduct a clinical trial, often referred to as a confirmatory study, to verify the anticipated clinical benefit of Leqembi.