Eisai Co., Ltd (TYO: 4523) and Biogen Inc. (NASDAQ: BIIB) have jointly announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of lecanemab, an amyloid-beta (Aβ) monoclonal antibody, for the treatment of adult patients with mild cognitive impairment and mild dementia due to Alzheimer’s disease (Early Alzheimer’s disease) who are apolipoprotein E ε4 (ApoE ε4) non-carriers or heterozygotes with confirmed amyloid pathology. This positive opinion follows a previous negative opinion in July, which led to a re-examination request by Eisai. A final decision by the EMA is anticipated within 67 days.
Lecanemab’s Mechanism of Action
Lecanemab selectively binds to both soluble Aβ aggregates (protofibrils) and insoluble Aβ aggregates (fibrils), which are major components of Aβ plaques found in Alzheimer’s disease (AD). By targeting these aggregates, lecanemab reduces the presence of Aβ protofibrils and Aβ plaques in the brain, potentially slowing the progression of the disease.
Clinical Trial Results and Global Impact
The global large Phase III Clarity AD study demonstrated the efficacy of lecanemab, showing that at 18 months, patients treated with lecanemab experienced a 27% reduction in the Clinical Dementia Rating Sum of Boxes (CDR-SB) score compared to the placebo group. This significant result supports the potential therapeutic benefit of lecanemab in early Alzheimer’s disease.-Fineline Info & Tech
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