Eisai Co., Ltd. (Tokyo, CEO: Haruo Naito) and Biogen Inc. (Cambridge, Massachusetts, CEO: Christopher A. Viehbacher) have announced the launch of Leqembi® (lecanemab) in Austria on August 25, 2025, followed by Germany on September 1, 2025. This marks the first availability of the drug in the European Union after receiving European Commission (EC) approval in April 2025.
Leqembi is the first approved therapy in Europe to target an underlying cause of Alzheimer’s disease (AD). It is indicated for adults diagnosed with mild cognitive impairment (MCI) and mild dementia due to AD (collectively referred to as early AD) who are ApoE ε4 non-carriers or heterozygotes with confirmed amyloid pathology.
Dual action: The drug targets both amyloid plaques and protofibrils, the toxic forms of amyloid beta believed to drive cognitive decline.
Clinical evidence: In the Clarity AD trial, Leqembi reduced clinical decline by 31% on the CDR-SB scale at 18 months compared to placebo in the EU-indicated population.
Safety profile: The most common side effects were infusion-related reactions (26%), ARIA-H (13%), headache (11%), and ARIA-E (9%). Symptomatic ARIA-E occurred in 2% of patients, while symptomatic ARIA-H occurred in 0.8%.
Following EC approval, Eisai has worked with regulators to implement a Controlled Access Program (CAP) in Austria and Germany, ensuring appropriate use and patient safety. Eisai leads global development and regulatory submissions for lecanemab, with Eisai and Biogen co-promoting the therapy in the EU. Eisai also serves as the Marketing Authorization Holder.
Alzheimer’s disease is a progressive condition marked by amyloid beta (Aβ) and tau accumulation, causing worsening cognitive decline over time. With limited treatment options available, Leqembi represents a significant step forward by slowing disease progression when started in the early stages.