Eisai And Biogen Launch LEQEMBI® First Therapy Targeting Alzheimer’s Cause In Austria and Germany Following EU Approval

Eisai Co., Ltd. and Biogen Inc. announced the European launch of LEQEMBI® (lecanemab), the first anti-amyloid beta monoclonal antibody therapy approved by the European Commission for Alzheimer’s disease (AD). LEQEMBI will be available in Austria on August 25, 2025, and in Germany on September 1, 2025, marking the first EU markets to introduce the therapy. It is indicated for adult patients with early AD with mild cognitive impairment or mild dementia who are ApoE ε4 non-carriers or heterozygotes with confirmed amyloid pathology.

Ahead of launch, Eisai collaborated with healthcare authorities to implement a controlled access program in Austria and Germany, ensuring appropriate patient eligibility and safety monitoring. LEQEMBI is the only therapy that fights AD in two ways, targeting both amyloid plaque and protofibrils, which may also influence downstream tau pathology, addressing one of the major hallmarks of disease progression.

In the Clarity AD Phase 3 clinical trial, LEQEMBI reduced clinical decline by 31% at 18 months on the Clinical Dementia Rating – Sum of Boxes (CDR-SB) scale in the EU indicated population compared with placebo. The most common side effects included infusion-related reactions (26%), ARIA-H (13%), headache (11%), and ARIA-E (9%), with symptomatic ARIA-E occurring in 2% of participants. Eisai leads global development and regulatory submissions, with Eisai and Biogen co-promoting the therapy in the EU.