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EU approves Leqembi for treatment of early Alzheimer’s disease

The European Commission has granted BioArctic’s partner Eisai’s application for Marketing Authorization of Leqembi (lecanemab) in the European Union (EU).
This is the first therapy targeting an underlying cause of Alzheimer’s disease (AD) to be granted an MA in the EU.
In the EU, Leqembi is indicated for the treatment of adult patients with a clinical diagnosis of mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease (early AD) who are apolipoprotein E ε4 (ApoE ε4) non-carriers or heterozygotes with confirmed amyloid pathology.
Leqembi’s Market Authorization applies to all 27 EU Member States as well as Iceland, Liechtenstein and Norway. Leqembi is already approved in the US, Japan, China, Great Britain and in other markets.
Published: April 15, 2025
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