FDA Grants Priority Review to Eisai and Biogen's Leqembi Auto-Injector Application

The U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to a supplemental Biologics License Application (sBLA) for a subcutaneous formulation of Leqembi (lecanemab), co-developed by Eisai and Biogen. The regulatory decision date is set for July 26, 2026. The auto-injector is designed for the treatment of early Alzheimer's disease. The FDA's Priority Review designation shortens the regulatory review timeline, indicating the agency views the subcutaneous version as potentially offering a significant therapeutic advantage over the currently approved intravenous infusion. Eisai leads the submission and commercialization of Leqembi.