Biogen : Canada Accepts New Drug Submission For Lecanemab As Treatment For Early Alzheimer's Disease

(RTTNews) - Eisai Co., Ltd. and Biogen Inc. (BIIB) said that Health Canada has accepted a New Drug Submission or NDS 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 in the brain.

Lecanemab was approved under the accelerated approval pathway in the U.S. and was launched in the U.S. on January 18, 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.

In the U.S., Eisai submitted a supplemental Biologics License Application (sBLA) to the FDA for approval under the traditional pathway on January 6, 2023.

On March 3, 2023, the FDA accepted Eisai's sBLA based on the Clarity AD clinical data, and the lecanemab application has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of July 6, 2023. The FDA is planning to hold an Advisory Committee to discuss this application on June 9, 2023.

In Japan, Eisai submitted an application for manufacturing and marketing approval to the Pharmaceuticals and Medical Devices Agency (PMDA) on January 16, 2023. Priority Review was granted by the Ministry of Health, Labour and Welfare (MHLW) on January 26, 2023.

In Europe, Eisai submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) on January 9, 2023, which was accepted on January 26, 2023.

In China, Eisai initiated submission of data for a BLA to the National Medical Products Administration (NMPA) of China in December 2022, and Priority Review was granted on February 27, 2023.