BioArctic AB's (publ) announced that the Scientific Advisory Group (SAG) will convene to discuss the Marketing Authorisation Application (MAA) of lecanemab (generic name, brand name: Leqembi®), which is currently under review by the European Medicines Agency (EMA). The meeting of the SAG is expected to take place during the first quarter of 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.

It is a commonly used procedure for new treatments and new treatment concepts. Eisai expects the European Commission's decision for the MAA of lecanemab in the second quarter of 2024, if the opinion from the CHMP is received by March 31, 2024, following discussion by the SAG. Eisai serves as the lead of Leqembi development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.

BioArctic has the right to commercialize lecanemab in the Nordic region, pending European approval, and currently Eisai and BioArctic are preparing for a joint commercialization in the region.