Eisai will request a reconsideration of this initial decision under Section 60 of the Therapeutic Goods Act within 90 days to make lecanemab available for eligible people living with early AD in Australia. Following Eisai's request for review, the TGA will issue a final decision within 60 days of receiving Eisai's request. Lecanemab is already approved in the United States, Japan, China, South Korea, Hong Kong, Israel UAE and Great Britain, and is being marketed in the United States, Japan and China.
Lecanemab is the result of a long-standing collaboration between BioArctic and Eisai, and the antibody was originally developed by BioArctic based on the work of Professor Lars Lannfelt and his discovery of the Arctic mutation in Alzheimer's disease. 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 and pending European approval Eisai and BioArctic are preparing for a joint commercialization in the region.
The information was released for public disclosure, through the agency of the contact persons below, on October 17, 2024, at 01.30 a.m.
CET. For further information, please contact: Oskar Bosson, VP Communications and IR E-mail: [email protected] Phone: +46 70 410 71 80 About lecanemab (Leqembi®) Lecanemab is the result of a strategic research allian.