Earlier this month, Austria and Germany became the first European Union markets to launch the anti-amyloid drug, lecanemab, following its European Commission marketing authorisation in April 2025. In a press release issued by Eisai and Biogen on 25 September, the launch of lecanemab in Austria occurred on 25 August, with Germany’s launch following on 1 September 2025. Lecanemab is indicated for adult patients with mild cognitive impairment or mild Alzheimer’s dementia (termed early AD) who are apolipoprotein E ε4 non-carriers or heterozygotes, with confirmed amyloid pathology. Controlled Access Programmes have been established in both countries, to ensure use of lecanemab in accordance with regulatory conditions and eligibility criteria.
In Germany, the German Center for Neurodegenerative Diseases (DZNE) has committed to scientifically accompany real-world use of lecanemab through its research network, coordinating across ten university hospitals to monitor outcomes, adverse events, biomarker data, and patient selection. This observational study aims to refine risk mitigation, particularly regarding monitoring for amyloid-related imaging abnormalities (ARIA) such as brain swelling or micro-bleeds. Read the press release: https://www.eisai.com/news/2025/news202557.html