The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive recommendation for the approval of lecanemab in the European Union. This decision supports the use of lecanemab for the treatment of early Alzheimer's disease in adult patients who are apolipoprotein E ε4 (ApoE ε4) heterozygotes or non-carriers. The recommendation follows Eisai's request for a re-examination of the CHMP's earlier negative recommendation. A final decision from the European Commission is expected within 67 days.
Clinical Evidence and Efficacy
The CHMP's recommendation is based on data from Eisai's global Clarity AD clinical trial, a Phase 3 study involving 1,795 patients with early Alzheimer's disease (mild cognitive impairment or mild dementia due to AD) and confirmed amyloid pathology. The trial demonstrated that lecanemab met its primary endpoint and all key secondary endpoints with statistically significant results. Specifically, in the recommended indicated population (ApoE ε4 heterozygotes or non-carriers), lecanemab reduced clinical decline on the Clinical Dementia Rating-Sum of Boxes (CDR-SB) scale by 33% at 18 months compared to placebo (difference, -0.58; 95% confidence interval [CI], -0.81 to -0.35; P<0.00001).
Impact on Daily Living
In addition to cognitive benefits, the trial also assessed the impact of lecanemab on activities of daily living. The Alzheimer's Disease Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS-MCI-ADL) showed 39% less decline in the lecanemab group compared to placebo at 18 months (difference, 2.2; 95% CI, 1.3 to 3.1; P<0.00001). This scale measures the ability of patients to function independently, including dressing, feeding themselves, and participating in community activities.
Safety Profile
The most common adverse reactions observed in the recommended indicated population were infusion-related reactions (26%), ARIA-H (amyloid-related imaging abnormalities with hemorrhage, 13%), falls (11%), headache (11%), and ARIA-E (amyloid-related imaging abnormalities with edema, 9%).
Global Approvals and Ongoing Studies
Lecanemab is already approved in the United States, Japan, China, South Korea, Hong Kong, Israel, the United Arab Emirates, and Great Britain. Eisai has also submitted applications for regulatory approval in 17 other countries and regions, including the European Union. Furthermore, Eisai's Phase 3 clinical study (AHEAD 3-45) with lecanemab in individuals with preclinical AD is ongoing, with full recruitment completed in October 2024. The Tau NexGen clinical study for Dominantly Inherited AD (DIAD) also includes lecanemab as the backbone anti-amyloid therapy.
Collaboration and Commercialization
BioArctic has a long-term collaboration with Eisai regarding the development and commercialization of drugs for the treatment of Alzheimer's disease. BioArctic has the rights to commercialize lecanemab in the Nordic region and is preparing for commercialization in these countries together with Eisai, pending approval from the European Commission.
Gunilla Osswald, CEO at BioArctic, stated, "We are very happy and grateful that the CHMP, during their re-examination of lecanemab, has recognized that for the patients in this population, the benefit of the treatment is greater than the risk. We now look forward to the European Commission's decision that is the next step towards providing access to this new treatment for patients in Europe with Alzheimer's disease."
