Eisai says SAG to discuss MAA for lecanemab by European Medicines Agency

Eisai (ESAIY) has announced an update on the regulatory review of lecanemab by the European Medicines Agency, Biogen (BIIB) announced. Eisai announced that the Scientific Advisory Group, or SAG, will convene to discuss the marketing authorization application, or MAA, of lecanemab, brand name Leqembi, which is currently under review by the European Medicines Agency, or EMA. “The meeting of the SAG is expected to take place during FY2023, which ends on March 31, 2024. The SAG is convened at the request of the Committee for Medicinal Products for Human Use – CHMP – of the EMA to provide independent advice on scientific or technical matters relating to products under evaluation by the CHMP, or on other scientific issues relevant to the work of the CHMP. Eisai expects the European Commission’s decision for the MAA of lecanemab in the first quarter of FY2024 ending June 30, 2024, if the opinion from the CHMP is received by March 31, 2024, following discussion by the SAG. Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen U.S. co-commercializing and co-promoting the product and Eisai having final decision-making authority,” the company stated.