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 with mild cognitive impairment (MCI) or mild dementia caused by Alzheimer's disease, specifically those who are apolipoprotein E ε4 (ApoE ε4) heterozygotes or non-carriers.
The CHMP's recommendation follows a re-examination of Eisai's marketing authorization application (MAA) for lecanemab. A final decision from the European Commission is anticipated within 67 days.
Clinical Trial Data
The recommendation is based on data from Eisai's Phase 3 Clarity AD clinical trial. This global, placebo-controlled, double-blind study involved 1,795 patients with early Alzheimer's disease, confirmed by the presence of amyloid pathology. The primary endpoint was the Clinical Dementia Rating-Sum of Boxes (CDR-SB), a global cognitive and functional scale.
In the Clarity AD trial, lecanemab demonstrated a 33% reduction in clinical decline on the CDR-SB scale at 18 months compared to placebo (difference, -0.58; 95% CI, -0.81 to -0.35; P<0.00001) in the recommended indicated population (ApoE ε4 heterozygotes or non-carriers). The mean CDR-SB score at baseline was approximately 3.2 in both groups. Additionally, the Alzheimer's Disease Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS-MCI-ADL) showed 39% less decline compared to placebo at 18 months (difference, 2.2; 95% CI, 1.3 to 3.1; P<0.00001).
Safety Profile
The most common adverse reactions observed in the Clarity AD trial within the recommended indicated population included infusion-related reactions (26%), ARIA-H (amyloid-related imaging abnormalities – hemorrhage, 13%), falls (11%), headache (11%), and ARIA-E (amyloid-related imaging abnormalities – edema, 9%).
Commercialization and Future Steps
Eisai is responsible for the clinical development, market approval applications, and commercialization of lecanemab. BioArctic retains the rights to commercialize lecanemab in the Nordic region and is preparing for joint commercialization with Eisai, pending approval from the European Commission.
"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," said Gunilla Osswald, CEO at BioArctic.
Lecanemab has already been approved in the United States, Japan, China, South Korea, Hong Kong, Israel, the United Arab Emirates, and Great Britain.
Ongoing Research
Eisai's Phase 3 clinical study (AHEAD 3-45) with lecanemab in individuals with preclinical AD is ongoing, with full recruitment achieved in October 2024. Furthermore, the Tau NexGen clinical study for Dominantly Inherited AD (DIAD), conducted by the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), includes lecanemab as the backbone anti-amyloid therapy.
