FDA Accepts Biogen and Eisai's LEQEMBI BLA for Subcutaneous Alzheimer's Treatment, PDUFA Date Set

Jan 15, 2025, 01:48 PM

The U.S. Food and Drug Administration (FDA) has accepted Biogen Inc. and Eisai Co. Ltd.'s Biologics License Application (BLA) for LEQEMBI (lecanemab-irmb), a treatment for early Alzheimer's disease, with a PDUFA action date set for August 31, 2025. The application seeks approval for a subcutaneous autoinjector (SC-AI) for weekly maintenance dosing, allowing for at-home administration. This development follows the announcement by Biogen and Eisai of the completion of the filing submission with the FDA.