Eisai and Biogen Announce the Official Launch of Their Humanized Anti-Soluble Aggregating Amyloid-Beta (Aβ) Monoclonal Antibody, Lecanemab (Brand Name: Leqembi®), in Austria on August 25, 2025, and in Germany on September 1, 2025. Lecanemab received approval from the European Commission (EC) in April 2025, becoming the first treatment targeting the underlying cause of Alzheimer's disease (AD). Lecanemab is indicated for the treatment of adult patients with early Alzheimer's disease (AD), clinically diagnosed with mild cognitive impairment or mild dementia, who are either non-carriers or heterozygous for apolipoprotein E ε4 (ApoE ε4) and have confirmed amyloid-beta pathology. Germany and Austria will be the first countries in the EU to launch this drug.
Following approval by the European Commission (EC), Eisai is working closely with healthcare regulatory authorities in various countries to advance preparations for the conditions related to market launch. Currently, Austria and Germany have officially established Controlled Access Programs, enabling the drug to be successfully launched in these two initial EU countries.
Eisai is leading the global development and registration application of lecanemab, while the product is jointly commercialized and promoted by Eisai and Biogen. Among them, Eisai has the final decision-making power. In the EU (excluding Nordic countries), Eisai and Biogen will jointly promote the drug, with Eisai as the marketing authorization holder responsible for the distribution of the product.
Note: This article is an excerpt of the original information. For detailed report content, please refer towww.eisai.com。
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