Eisai has submitted a marketing authorization application or MAA 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 to the European Medicines Agency, Eisai Co., Ltd. and Biogen Inc. (BIIB) said in a statement on Tuesday.
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. Eisai submitted a Supplemental Biologics License Application (sBLA) to the FDA for approval under the traditional pathway on the same day.
In China, Eisai has initiated submission of data for BLA to the National Medical Products Administration of China in December 2022. In Japan, Eisai plans to submit a marketing authorization application by the end of Eisai's fiscal year 2022, which ends March 31, 2023.
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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