By Fineline Cube 
Eisai Co., Ltd. (TYO: 4523) and Biogen Inc. (NASDAQ: BIIB) jointly announced that they have received marketing approval from the European Commission (EC) for their amyloid-beta (Aβ) monoclonal antibody (mAb) Leqembi (lecanemab). This approval establishes Leqembi as the first therapy in the EU targeting the underlying pathology of Alzheimer’s disease (AD). The drug is now approved to treat adult patients with mild cognitive impairment (MCI) and mild dementia due to AD, including those who are apolipoprotein E ε4 (ApoE ε4) non-carriers or heterozygotes, with confirmed amyloid pathology across all 27 EU member states, as well as Iceland, Liechtenstein, and Norway.
Mechanism of Action
Leqembi is the world’s only approved Aβ mAb that uniquely addresses dual pathological hallmarks of Alzheimer’s disease. It preferentially neutralizes soluble Aβ protofibrils, which are neurotoxic intermediates implicated in synaptic dysfunction, while also reducing the burden of insoluble Aβ plaques, a key pathological feature of AD progression. This dual action positions Leqembi as a significant advancement in the treatment landscape for early Alzheimer’s disease.
Market and Patient Impact
The approval of Leqembi in the EU marks a pivotal moment for patients with early AD, offering a new therapeutic option that targets the disease’s underlying pathology. By reducing both soluble and insoluble Aβ species, Leqembi has the potential to slow cognitive decline and improve quality of life for patients in the early stages of the disease.-Fineline Info & Tech