LEQEMBI Launches in Austria and Germany as First Anti-Amyloid Alzheimer's Therapy in EU
核心洞察
Eisai and Biogen launched LEQEMBI (lecanemab) in Austria on August 25, 2025, and Germany on September 1, 2025, marking the first EU markets to introduce this anti-amyloid beta (搜索) monoclonal antibody therapy.
The therapy is indicated for early Alzheimer's disease (搜索) patients with mild cognitive impairment (搜索) or mild dementia (搜索) who are ApoE ε4 non-carriers or heterozygotes with confirmed amyloid pathology.
In the Clarity AD Phase 3 trial, LEQEMBI reduced clinical decline by 31% at 18 months compared to placebo in the EU indicated population.
Eisai Co., Ltd. and Biogen Inc. have launched LEQEMBI® (lecanemab) in Austria and Germany, making these the first European Union markets to introduce the groundbreaking anti-amyloid beta (搜索) monoclonal antibody therapy for Alzheimer's disease (搜索). The therapy became available in Austria on August 25, 2025, with Germany following on September 1, 2025.
LEQEMBI received European Commission approval in April 2025 as the first therapy that targets an underlying cause of Alzheimer's disease (搜索). The therapy is indicated for adult patients with a clinical diagnosis of mild cognitive impairment (搜索) and mild dementia (搜索) due to AD, collectively referred to as early AD, who are apolipoprotein E ε4 (搜索) non-carriers or heterozygotes with confirmed amyloid pathology.
Controlled Access Implementation
Following EC approval, Eisai collaborated with regional and local healthcare authorities to implement mandatory authorization requirements ahead of launch. The required controlled access program is now in place in Austria and Germany, ensuring appropriate patient eligibility and safety monitoring for the therapy's introduction in these first two EU countries.
Dual-Target Mechanism of Action
LEQEMBI represents a unique approach to Alzheimer's treatment, being the only therapy that fights AD in two ways by targeting both amyloid plaque (搜索) and protofibrils (搜索). This dual mechanism may also influence downstream tau (搜索) pathology, addressing major hallmarks of disease progression. Alzheimer's disease (搜索) is characterized by amyloid beta (搜索) and tau as key pathological features, progressing in stages that increase in severity over time.
Clinical Trial Results
In the Clarity AD Phase 3 clinical trial, LEQEMBI demonstrated significant efficacy in the EU indicated population. The primary endpoint was measured using the Clinical Dementia Rating - Sum of Boxes (CDR-SB) scale, a global cognitive and functional assessment. Treatment with lecanemab in 757 patients from the EU indicated population reduced clinical decline on CDR-SB by 31% at 18 months compared to placebo in 764 patients, using controlled-based multiple imputation analysis.
Safety Profile
The most common adverse reactions in the EU indicated population included infusion-related reactions occurring in 26% of patients, ARIA-H in 13%, headache in 11%, and ARIA-E in 9% of participants. Symptomatic ARIA-E occurred in 2% of participants, while symptomatic ARIA-H occurred in 0.8% of patients.
Commercial Partnership
Eisai serves as the lead for lecanemab's development and regulatory submissions globally, with both companies co-commercializing and co-promoting the product while Eisai maintains final decision-making authority. In the EU, excluding Nordic countries, Eisai and Biogen will co-promote the medicine, with Eisai distributing the product as the Marketing Authorization Holder.
The launch addresses a significant unmet medical need for treatment options that slow AD progression by initiating therapy from its early stage, potentially reducing the overall burden on people affected by AD and society.