FDA Grants Priority Review for Eisai/Biogen's Leqembi in Early Alzheimer's

The U.S. Food and Drug Administration has accepted and granted priority review to a supplemental biologics license application (sBLA) for Eisai and Biogen's Leqembi, seeking to expand its use to treat early Alzheimer's disease. A decision is expected by July 26, 2026. The priority review designation shortens the FDA's review timeline. Leqembi (lecanemab) is currently approved under the accelerated pathway for treating Alzheimer's disease. The sBLA aims for traditional approval and an expanded label for early disease, which could significantly broaden the drug's eligible patient population and commercial potential.