Austria and Germany First in EU to Launch LEQEMBI

Eisai Co., Ltd. and Biogen Inc. shared that LEQEMBI (lecanemab), an anti-amyloid beta monoclonal antibody, launched in Austria on August 25, 2025. It will launch in Germany on September 1, 2025. These mark the first European Union (EU) markets for the therapy.

In April 2025, the European Commission approved LEQEMBI. It’s the first treatment to directly target a main cause of Alzheimer’s disease (AD). It’s for adults with early Alzheimer’s disease. This includes those with mild cognitive impairment or mild dementia. This applies to ApoE4 non-carriers or heterozygotes with confirmed amyloid pathology.

Eisai has teamed up with healthcare authorities to create a controlled access program. This program is now active in Austria and Germany. LEQEMBI is the only treatment that targets amyloid plaques and protofibrils. This may affect tau pathology later on.
In the Clarity AD trial, treatment cut clinical decline by 31% at 18 months compared to placebo. This was measured using the CDR-SB scale in the targeted group. Common adverse events included infusion-related reactions (26%), ARIA-H (13%), headache (11%), and ARIA-E (9%).

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Eisai manages global development and regulatory tasks. Eisai and Biogen also co-promote the product. In the EU, except for the Nordic countries, Eisai is the Marketing Authorization Holder and distributor.