Eisai, Biogen say FDA accepted sBLA for monthly LEQEMBI IV maintenance dosing

Eisai and Biogen announced today that the U.S. Food and Drug Administration has accepted Eisai’s Supplemental Biologics License Application for monthly lecanemab-irmb — U.S. brand name LEQEMBI — intravenous maintenance dosing. A Prescription Drug User Fee Act, or PDUFA, action date is set for January 25, 2025. LEQEMBI is indicated for the treatment of Alzheimer’s disease in patients with mild cognitive impairment or mild dementia stage of disease. As part of the proposed monthly IV maintenance regimen, the patients who have completed the biweekly IV initiation phase, exact period under discussion with the FDA, would receive a monthly IV dose that maintains effective drug concentration to sustain the clearance of highly toxic protofibrils which can continue to cause neuronal injury. The sBLA is based on modeling of observed data from the Phase 2 study and its open-label extension as well as the Clarity AD study and its OLE study. Additionally, Eisai initiated the rolling submission of a BLA to the FDA for the LEQEMBI subcutaneous autoinjector for weekly maintenance dosing after it was granted Fast Track designation by the FDA in May 2024. Eisai serves as the lead for lecanemab’s development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.