The European Medicines Agency’s (EMA) human medicines committee (CHMP) has recommended marketing authorization for Leqembi (lecanemab) to treat early Alzheimer’s disease in patients with mild cognitive impairment or mild dementia who carry one or no copies of the ApoE4 gene.
This recommendation follows a re-examination of the drug’s benefits and risks, concluding that it is suitable for a restricted patient population less prone to serious side effects like amyloid-related imaging abnormalities (ARIA).
Data indicated that Leqembi slows cognitive decline in eligible patients, with subgroup analyses showing a reduced incidence of ARIA compared to broader populations. Among patients with one or no copies of the ApoE4 gene, 8.9% experienced ARIA-E (brain swelling), and 12.9% experienced ARIA-H (brain bleeding), compared to higher rates in patients with two ApoE4 copies. Effectiveness measures, including cognitive assessments over 18 months, demonstrated slower progression of Alzheimer’s symptoms in the restricted group.
The CHMP emphasized risk minimization measures for Leqembi’s use, requiring MRI monitoring before and during treatment to detect ARIA early. Additional safety efforts include educational tools for healthcare providers, patient alert cards, and a post-authorization safety study to assess long-term effects and further refine safety protocols. Leqembi will be available through a controlled access program to ensure its use aligns with the recommended patient criteria.
If authorized, individual Member States will determine pricing and reimbursement policies. Leqembi, administered biweekly as an infusion, works by targeting and reducing amyloid beta plaques, a hallmark of Alzheimer’s disease progression.