EMA Endorses Leqembi for Early Alzheimer's Treatment

The European Medicines Agency’s (EMA) human medicines committee (CHMP) has endorsed the marketing authorization of Leqembi (lecanemab) for the treatment of early Alzheimer’s disease in patients exhibiting mild cognitive impairment or mild dementia. This recommendation is specifically for patients who possess either one or no copies of the ApoE4 gene.

This recommendation came following a thorough re-evaluation of the drug's benefits and risks, ultimately determining its suitability for a targeted patient group that is less susceptible to severe side effects, such as amyloid-related imaging abnormalities (ARIA). Clinical data have demonstrated that Leqembi can effectively slow cognitive decline in patients who meet the eligibility criteria. Subgroup analyses revealed that patients carrying one or no copies of the ApoE4 gene experienced a lower incidence of ARIA compared to those with two copies of the gene. Specifically, 8.9% of these patients experienced ARIA-E (brain swelling), and 12.9% experienced ARIA-H (brain bleeding), which are lower rates than those observed in patients with two copies of ApoE4.

Effectiveness of Leqembi was measured through cognitive assessments conducted over an 18-month period, which showed a slower progression of Alzheimer’s symptoms in the targeted patient group. To ensure safe use of Leqembi, the CHMP stressed the importance of risk minimization measures. These include mandatory MRI monitoring both before and during treatment to detect ARIA early. Other safety measures consist of educational tools for healthcare providers, patient alert cards, and a post-authorization safety study to evaluate long-term effects and refine safety protocols.

Leqembi will be available through a controlled access program, ensuring that its use adheres to the recommended patient criteria. Upon authorization, individual Member States will be responsible for determining the pricing and reimbursement policies for Leqembi. The drug is administered biweekly as an infusion and works by targeting and reducing amyloid beta plaques, which are considered a hallmark of Alzheimer’s disease progression.