The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive recommendation for the approval of lecanemab for the treatment of early Alzheimer's disease in the European Union. This decision supports the use of lecanemab 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 Eisai's request for a re-examination after an initial negative recommendation. A final decision from the European Commission regarding marketing authorization is anticipated within 67 days.
Gunilla Osswald, CEO of BioArctic, expressed gratitude that the CHMP recognized the benefit of lecanemab outweighs the risk for the specified patient population. BioArctic and Eisai are now preparing for joint commercialization in the Nordic region, pending the European Commission's approval.
Lecanemab, marketed as Leqembi, is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody that targets aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ). It is designed to reduce amyloid plaques in the brain, a hallmark of Alzheimer's disease.
Lecanemab's efficacy was demonstrated in Eisai's global Clarity AD clinical trial, a Phase 3, placebo-controlled, double-blind study involving 1,795 patients with early Alzheimer's disease. The trial met its primary endpoint, showing a statistically significant reduction in clinical decline on the Clinical Dementia Rating-Sum of Boxes (CDR-SB) scale. Specifically, in the recommended indicated population (ApoE ε4 heterozygotes or non-carriers), lecanemab reduced clinical decline by 33% at 18 months compared to placebo (difference, -0.58; 95% confidence interval [CI], -0.81 to -0.35; P<0.00001).
Secondary endpoints also showed significant benefits. The Alzheimer's Disease Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS-MCI-ADL) indicated 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).
The most common adverse reactions observed in the Clarity AD trial within the recommended population included 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%).
Eisai has also submitted applications for regulatory approval of lecanemab in 17 other countries and regions. Additionally, a supplemental Biologics License Application (sBLA) for less frequent intravenous maintenance dosing and a Biologics License Application (BLA) for maintenance dosing of a subcutaneous injection formulation are under review by the U.S. FDA.
Further studies are ongoing, including Eisai's Phase 3 clinical study (AHEAD 3-45) in individuals with preclinical Alzheimer's disease and the Tau NexGen clinical study for Dominantly Inherited AD (DIAD), where lecanemab is being used as the backbone anti-amyloid therapy.
BioArctic and Eisai have a long-standing collaboration since 2005, focusing on the development and commercialization of drugs for Alzheimer's disease. BioArctic retains the rights to commercialize lecanemab in the Nordic region and is entitled to payments related to regulatory approvals, sales milestones, and royalties on global sales.
