Eisai, Biogen announce sBLA submission for monthly LEQEMBI IV maintenance dosing

Eisai and Biogen announced that Eisai submitted to the U.S. Food and Drug Administration a Supplemental Biologics License Application, or sBLA, for monthly lecanemab-irmb — U.S. brand name: LEQEMBI – intravenous maintenance dosing. 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 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 even after the amyloid-beta plaque has been cleared from the brain. The sBLA is based on modeling of observed data from the Phase 2 study and its open-label extension as well as Clarity AD study and its OLE study. Eisai had aimed to submit a Biologics License Application for weekly maintenance therapy using subcutaneous administration in March 2024. To respond to the FDA’s recent requirement of additional three-month immunogenicity data at the proposed maintenance dose of 360 mg weekly, Eisai planned to initiate a rolling BLA for lecanemab SC maintenance in March 2024, under the existing Fast Track and Breakthrough Therapy designations. However, Eisai was recently informed by the FDA that a Fast Track designation specific for the SC formulation is needed to receive rolling review. Following the guidance, Eisai submitted a request for Fast Track designation for the SC formulation and will initiate a rolling submission should the FDA grant this designation. The Fast Track designation will be determined within 60 days from the March 2024 submission.