Leqembi received the European Commission (EC) approval in April 2025 as the first therapy that targets an underlying cause of Alzheimer’s disease (AD). It is indicated for the treatment of adult patients with a clinical diagnosis of mild cognitive impairment (MCI) and mild dementia due to AD (early AD) who are apolipoprotein E ε4 non-carriers or heterozygotes with confirmed amyloid pathology.

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Following the EC approval, Eisai has been collaborating with the regional and local healthcare authorities to implement the mandatory authorisation requirements ahead of launch. The required controlled access program is now in place in Austria and Germany, enabling the launch in these first two EU countries.

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Leqembi 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 is responsible for the clinical development, applications for market approval and commercialization of Leqembi for Alzheimer’s disease. BioArctic has the right to commercialize Leqembi in the Nordic region together with Eisai and the two companies are preparing for a joint commercialization in the region.