FDA Grants Traditional Approval for Alzheimer's Drug Leqembi, Providing Widespread Access and Hope
The U.S. Food and Drug Administration (FDA) has converted Leqembi (lecanemab-irmb), a treatment for Alzheimer's Disease, from accelerated approval to traditional approval after a confirmatory trial verified its clinical benefit. Leqembi is the first amyloid beta-directed antibody to receive traditional approval for Alzheimer's disease. The drug works by reducing amyloid plaques in the brain, a key characteristic of the disease. Alzheimer's disease affects over 6.5 million Americans and causes memory loss and cognitive decline. Leqembi demonstrated a significant reduction in decline compared to placebo in a Phase 3 clinical trial. The most common side effects of Leqembi include headache, infusion-related reactions, and amyloid-related imaging abnormalities.
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