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Austria and Germany have become the first European Union markets to introduce LEQEMBI® (lecanemab), a treatment developed by Eisai and Biogen that targets the underlying causes of Alzheimer’s disease.
The therapy, an anti-amyloid beta monoclonal antibody, was approved by the European Commission in April 2025 for patients with early Alzheimer’s disease who are apolipoprotein E4 non-carriers or heterozygotes with confirmed amyloid pathology. Launches took place in Austria on 25 August, with Germany following on 1 September.
LEQEMBI acts by targeting both amyloid plaque and protofibrils, which can influence tau pathology downstream. In the pivotal Clarity AD clinical trial, treatment reduced clinical decline by 31% over 18 months compared with placebo in the approved population.
Common side effects included infusion-related reactions, headache, and amyloid-related imaging abnormalities (ARIA). Symptomatic ARIA-E occurred in 2% of participants, while symptomatic ARIA-H was reported in fewer than 1%.
Eisai leads global development and regulatory submissions for lecanemab, with Biogen co-commercialising and co-promoting the therapy. The companies are working with regional health authorities to implement controlled access programmes to ensure appropriate patient use in Europe.
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