Eisai Co., Ltd (TYO: 4523) and Biogen Inc. (NASDAQ: BIIB) have announced that their co-developed drug, Leqembi (lecanemab), a humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody, has been approved by the Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) in Mexico. This approval marks another milestone in the treatment of patients with early Alzheimer’s disease (AD).
Leqembi’s Mechanism of Action and Global Impact
Leqembi selectively binds to soluble Aβ aggregates (protofibrils) and insoluble Aβ aggregates (fibrils), which are major components of Aβ plaques found in the brains of Alzheimer’s patients. By reducing both Aβ protofibrils and Aβ plaques, Leqembi has the potential to alter the course of the disease. The drug has already received marketing approvals in the U.S., Japan, China, South Korea, Hong Kong, Israel, the United Arab Emirates, and Great Britain, highlighting its global reach and impact on Alzheimer’s treatment.
Phase III Clarity AD Study and Approval Basis
The approval in Mexico is based on the positive results from the large, global Phase III Clarity AD study, which met its primary endpoint and all key secondary endpoints with statistically significant benefits. This robust clinical data supports the efficacy and safety profile of Leqembi in the treatment of early Alzheimer’s disease.
Global Development and Commercialization Strategy
Eisai leads the global development and regulatory filing activities for Leqembi, with both Eisai and Biogen co-commercializing and co-promoting the product worldwide. In Mexico, they will share the commercialization and promotion responsibilities, ensuring that patients have access to this innovative therapy for Alzheimer’s disease.-Fineline Info & Tech
