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Highlights

  • LEQEMBI launched in Austria on August 25 and will launch in Germany on September 1, 2025.
  • EC approved lecanemab for early Alzheimer’s disease in April 2025 for specific patients.
  • Clarity AD showed a 31% reduction in CDR-SB decline at 18 months versus placebo.

Eisai Co., Ltd. and Biogen Inc. announced the first European launches of LEQEMBI® (lecanemab) in Austria on August 25, 2025, with Germany to follow on September 1, 2025 — the initial rollout following the European Commission’s marketing authorisation in April 2025. These are the first EU commercial launches for the anti-amyloid beta monoclonal antibody authorised for a defined subset of early Alzheimer’s disease (AD) patients.

The EC approval covers adult patients with mild cognitive impairment or mild dementia due to AD (early AD) who are apolipoprotein E ε4 non-carriers or heterozygotes and have confirmed amyloid pathology. Regulatory materials and the European Public Assessment Report set out the indication and risk-management requirements that underpin controlled access in member states.

Implementation of mandatory authorisation and controlled access programmes has been completed for Austria and Germany, enabling treatment delivery under the specified conditions and monitoring frameworks. Eisai said these measures are intended to ensure appropriate patient selection and safety monitoring in the early rollout.

Clinical context for the approval draws on the Clarity AD Phase 3 dataset. In the EU-indicated population (ApoE ε4 non-carriers or heterozygotes), treatment with lecanemab (n=757) reduced clinical decline on the Clinical Dementia Rating—Sum of Boxes (CDR-SB) by 31% at 18 months versus placebo (n=764). Reported common adverse reactions in that population included infusion-related reactions (26%), ARIA-H (13%), headache (11%) and ARIA-E (9%), with symptomatic ARIA-E occurring in approximately 2% of participants.

Commercially and operationally, Eisai leads development and regulatory submissions globally, with Eisai and Biogen co-commercialising in many regions; Eisai serves as Marketing Authorisation Holder and has final decision-making authority for lecanemab’s EU rollout (excluding the Nordics). Market observers and healthcare payers will now evaluate how controlled access, monitoring requirements and clinical benefit measurements translate into clinical adoption and reimbursement decisions across EU health systems.