Eisai Submits Leqembi SBLA For IV Maintenance Dosing In Early Alzheimer's Disease

(RTTNews) - 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 or IV maintenance dosing, Eisai Co., Ltd. and Biogen Inc. (BIIB) said in a statement.

Leqembi is indicated for the treatment of Alzheimer's disease (AD) in patients with mild cognitive impairment or mild dementia stage of disease --collectively referred to as early Alzheimer's disease.

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 (BLA) for weekly maintenance therapy using subcutaneous (SC) 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.

Leqembi is now approved in the U.S., Japan and China, and applications have been submitted for review in the European Union, Australia, Brazil, Canada, Hong Kong, Great Britain, India, Israel, Russia, Saudi Arabia, South Korea, Taiwan, Singapore, and Switzerland.

Eisai serves as the lead for lecanemab's development and regulatory submissions globally with both companies co-commercializing and co-promoting the product and Eisai having final decision-making authority.

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