By Fineline Cube 
Partners Eisai Co., Ltd (TYO: 4523) and Biogen Inc. (NASDAQ: BIIB) have announced that the US Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) for Leqembi (lecanemab) subcutaneous autoinjector (SC-AI) for review. The application seeks approval for the treatment of Alzheimer’s disease (AD) in patients with Mild Cognitive Impairment (MCI) or mild dementia stage of the disease.
Leqembi: Mechanism of Action and Global Approvals
Leqembi is designed to selectively bind to both soluble Aβ aggregates (protofibrils) and insoluble Aβ aggregates (fibrils), which are major components of Aβ plaques in the brain. By reducing these aggregates, Leqembi aims to slow the progression of Alzheimer’s disease. The drug has already received marketing approvals in the US, Japan, China, South Korea, Hong Kong, Israel, the United Arab Emirates, Great Britain, and Mexico, highlighting its potential as a significant treatment option for Alzheimer’s patients globally.
Development and Commercialization Strategy
Eisai leads the global development and regulatory filing activities for Leqembi, working closely with Biogen. Both companies are co-commercializing and co-promoting the product, with Eisai holding final decision-making authority. This collaborative approach leverages the strengths of both partners to ensure the successful development, approval, and commercialization of Leqembi, aiming to improve the lives of patients affected by Alzheimer’s disease.-Fineline Info & Tech