Eisai, Biogen say LEQEMBI approved for treatment of early AD in Mexico

Eisai (ESALY) and Biogen (BIIB) announced that the Federal Commission for the Protection Against Sanitary Risk in Mexico has approved humanized anti-soluble aggregated amyloid-beta monoclonal antibody “LEQEMBI” for the treatment of early Alzheimer’s disease. LEQEMBI selectively binds to soluble Abeta aggregates, as well as insoluble Abeta aggregates which are a major component of Abeta plaques, thereby reducing both Abeta protofibrils and Abeta plaques in the brain. LEQEMBI is the first approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline through this mechanism. LEQEMBI is also approved and being marketed in the U.S., Japan, China, South Korea, Hong Kong, Israel, the United Arab Emirates, and Great Britain. LEQEMBI’s approval is based on the large global Phase 3 Clarity AD study. In the Clarity AD study, LEQEMBI met its primary endpoint and all key secondary endpoints with statistically significant results.