(RTTNews) - Eisai Co., Ltd. (ESALF.PK) and Biogen Inc. (BIIB) announced that the Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) in Mexico has approved humanized anti-soluble aggregated amyloid-beta monoclonal antibody "LEQEMBI" (lecanemab) for the treatment of early Alzheimer's disease.
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 Alzheimer's disease study. In the Clarity Alzheimer's disease study, LEQEMBI met its primary endpoint and all key secondary endpoints with statistically significant results.
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