On April 15, 2025, Eisai Co., Ltd. and Biogen Inc. announced that the European Commission (EC) granted Marketing Authorization (MA) for Leqembi® (lecanemab) in the European Union. This landmark decision makes Leqembi the first therapy targeting an underlying cause of Alzheimer’s disease (AD) to be authorized in the EU, representing a significant advancement in the treatment of this debilitating condition.
Leqembi is indicated for the treatment of adult patients with a clinical diagnosis of mild cognitive impairment and mild dementia due to AD (early AD) who are apolipoprotein E ε4 (ApoE ε4) non-carriers or heterozygotes with confirmed amyloid pathology. The MA applies to all 27 EU Member States, as well as Iceland, Liechtenstein, and Norway, opening a substantial new market for the drug.
Leqembi is the only approved amyloid-beta monoclonal antibody that preferentially binds and clears toxic protofibrils, in addition to targeting and reducing amyloid-beta plaques. This dual mechanism addresses a key pathological driver of AD. With an estimated 6.9 million people affected by AD dementia in Europe, this authorization provides a crucial new treatment option for eligible patients and their families, and significantly expands Biogen's global commercial reach.
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