US EditionLeqembi® (Lecanemab) Launched in the EU Today
LEQEMBI, targeting early Alzheimer's underlying causes, reduces clinical decline by 31% at 18 months in specific genetic populations, launched first in Austria and Germany.
- On August 25, 2025, Eisai Co., Ltd. and Biogen Inc. announced LEQEMBI's launch in Austria, with Germany set for September 1, 2025, marking their first EU market launches.
- Following EC approval in April 2025, LEQEMBI became the first therapy targeting Alzheimer's' root cause, with a controlled access program in Austria and Germany addressing an unmet clinical need in early Alzheimer's disease.
- Phase 3 Clarity AD clinical trial showed lecanemab reduced clinical decline by 31% and ADCS MCI-ADL decline by 33% at 18 months versus placebo, with common adverse reactions including infusion-related reactions.
- The launches give the partners first-mover advantage in Austria and Germany, with Eisai leading development and Biogen sharing commercial upside in substantial EU market expansion.
- The drug's EU indication specifies LEQEMBI for adult MCI and mild dementia patients who are ApoE ε4 non-carriers or heterozygotes, with FDA BLA accepted and PDUFA action date August 31, 2025; it is approved in 48 countries.
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The Record
Austria and Germany to become the first markets in the European Union (EU) to launch LEQEMBI® (lecanemab)
TOKYO and CAMBRIDGE, Mass., Aug. 25, 2025 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today that the anti-amyloid beta (Aβ)…
Austria and Germany to become the first markets in the European Union (EU) to launch LEQEMBI(R) (lecanemab) – DIR HONGKONG
TOKYO and CAMBRIDGE, Mass., August 25, 2025 – (JCN Newswire via SeaPRwire.com) – Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today that the anti-amyloid beta(AB) monoclonal antibody “LEQEMBI®” has been launched in Austria on August 25, 2025 and will be launched in Germany on September 1, 2025. …
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