The European Medicines Agency has accepted a marketing authorization application for lecanemab (Brand Name in the U.S.: LEQEMBI), an investigational anti-amyloid beta (Aß) protofibril antibody, for the treatment of early Alzheimer's disease with confirmed amyloid pathology, for review following a standard timeline, Eisai Co., Ltd. and Biogen Inc. (BIIB) said in a statement.
In the U.S., lecanemab was granted accelerated approval as a treatment for Alzheimer's disease by the U.S. Food and Drug Administration on January 6, 2023. On the same day, Eisai submitted a Supplemental Biologics License Application to the FDA for approval under the traditional pathway based on the results from the Phase III Clarity AD confirmatory study.
In Japan, Eisai submitted a marketing authorization application to the Pharmaceuticals and Medical Devices Agency on January 16, 2023.
In China, Eisai has initiated submission of data for a BLA to the National Medical Products Administration (NMPA) of China in December 2022.
Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.
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