14 November 2024: The EMA has today partially approved a marketing application for Leqembi (Biogen/Eisai), having previously rejected it it July 2024, saying that the side effects outweighed the benefits.
“After re-examining its initial opinion, the EMA… has recommended granting marketing authorisation to Leqembi (lecanemab) for treating mild cognitive impairment or mild dementia due to Alzheimer’s disease,” the European Medicines Agency said.
Treatment will only apply to a certain group of patients, excluding those taking anticoagulants, and including those who have “only one copy or no copy of ApoE4”, a type of gene known as an important risk factor for Alzheimer’s. During the re-examination, the CHMP focused on participants with only one or no copies of the ApoE4 gene, assessing data from a subgroup of 1,521 individuals out of the 1,795 participants in the Clarity-AD trial of lecanemab. In this group, the risk of amyloid-related imaging abnormalities (ARIA) was generally lower than in the full trial population, which included people with two copies of the ApoE4 gene.
The CHMP also requires the companies (Eisai and Biogen) to conduct a post-marketing authorisation safety study. Eisai and Biogen have committed to increase awareness of ARIA and ensure early management of side-effects, by providing guidance and training for healthcare professionals, as well as an alert card for patients. The companies will also set up an EU-wide registry study to estimate the incidence and severity of side effects and collect information about patients’ progression to the next stages of Alzheimer’s disease.
The positive CHMP opinion means that a European Commission Marketing Authorisation Application decision is expected within 67 days, in accordance with the European Medicine Agency regulatory process.
As with many other conditions, this first drug with a new mode of action constitutes an important advance for the Alzheimer’s disease community in Europe. We therefore welcome the positive outcome from the CHMP’s re-examination of lecanemab. In our position paper on anti-amyloid therapies, we called for timely, safe and equitable access to these medicines. We now look to companies to adopt reasonable and sustainable pricing policies and to payers to ensure lecanemab is covered by national reimbursement systems. Healthcare systems must also be adapted, so that people can receive an accurate, timely diagnosis with access to treatment and effective monitoring for potential side effects. The side effects and benefits of lecanemab will need to be communicated to people with early Alzheimer’s disease in realistic terms, in order to allow informed decision-making.
Jean Georges, Executive Director of Alzheimer Europe
