Eisai Seeks FDA Approval for Monthly IV Dosing of LEQEMBI for Alzheimer’s Disease Treatment

1. FDA Acceptance: The FDA has accepted Eisai's supplemental biologics license application (sBLA) for a new monthly intravenous (IV) maintenance dosing of LEQEMBI (lecanemab-irmb) for the treatment of Alzheimer's disease (AD) in patients with mild cognitive impairment or mild dementia stage of disease.
2. PDUFA Action Date: The FDA has set a Prescription Drug User Fee Act (PDUFA) action date for January 25, 2025, to provide a final decision on the sBLA.
3. Monthly IV Maintenance: The proposed monthly IV maintenance regimen aims to maintain effective drug concentration to sustain the clearance of highly toxic protofibrils, which can continue to cause neuronal injury.
4. Subcutaneous Autoinjector: Eisai has initiated a rolling submission of a biologics license application (BLA) to the FDA for a subcutaneous autoinjector version of LEQEMBI, which gained Fast Track designation in May 2024.
5. Current Status: LEQEMBI is currently approved in the U.S., Japan, China, and South Korea, and applications are pending in 13 other countries and regions, including the European Union.