Austria and Germany to end up being the very first markets in the European Union (EU) to introduce LEQEMBI(R) (lecanemab)

TOKYO and CAMBRIDGE, Mass., August 25, 2025 – (JCN Newswire) – Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate head office: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) revealed today that the anti-amyloid beta(AB) monoclonal antibody “LEQEMBI ®” has actually been released in Austria on August 25, 2025 and will be introduced in Germany on September 1, 2025. LEQEMBI got the European Commission (EC) approval in April 2025 as the very first treatment that targets a hidden reason for Alzheimer’s illness (ADVERTISEMENT). It is suggested for the treatment of adult clients with a medical diagnosis of moderate cognitive problems(MCI) and moderate dementia due to advertisement (jointly described as early advertisement) who are apolipo protein E 4(ApoE 4 *) non-carriers or heterozygotes with verified amyloid pathology.1 Germany and Austria will mark the very first launches in the EU.

Following the EC approval, Eisai has actually been teaming up with the local and regional health care authorities to execute the obligatory authorisation requirements ahead of launch. The needed regulated gain access to program ** is now in location in Austria and Germany, allowing the launch in these very first 2 EU nations.

Advertisement is a progressive, ruthless illness with AB and tau as trademarks. Advertisement advances in phases that increase in seriousness gradually, and each phase of the illness provides various difficulties for those coping with advertisement and their care partners. There is a considerable unmet requirement for brand-new treatment choices that slow the development of advertisement by starting treatment from its early phase and continuing it in order to lower the total problem on individuals impacted by advertisement and society. Just LEQEMBI battles advertisement in 2 methods – targeting both amyloid plaque and protofibrils ***, which can affect tau downstream.

In the Clarity advertisement medical trial, the main endpoint was the international cognitive and practical scale, Clinical Dementia Rating– Sum of Boxes (CDR-SB).1 Treatment with lecanemab (n=757), in the EU suggested population (ApoE 4 non-carriers or heterozygotes, determined by controlled-based numerous imputation), lowered medical decrease on CDR-SB by 31% at 18 months compared to placebo (n=764).1

In the EU suggested population (ApoE 4 non-carriers or heterozygotes) (n=757), the most typical negative responses were infusion-related response (26%), ARIA-H (13%), headache (11%) and ARIA-E(9%). Symptomatic ARIA-E happened in 2% of individuals. Symptomatic ARIA-H happened in 0.8% of clients.1

Eisai works as the lead for lecanemab’s advancement and regulative submissions worldwide with both Eisai and Biogen co-commercializing and co-promoting the item and Eisai having decision making authority. In the EU (leaving out the Nordic nations), Eisai and Biogen will co-promote the medication, with Eisai dispersing the item as the Marketing Authorization Holder.

< strong data-start ="34" data-end ="69"> For more information, please see: https://www.eisai.com/news/2025/pdf/enews202557pdf.pdf

Subject: Press release summary