CHMP Reaffirms Positive Opinion for Lecanemab in Early Alzheimer's Disease

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has reaffirmed its positive opinion on lecanemab, a humanized monoclonal antibody developed by Eisai and Biogen, for the treatment of early Alzheimer's disease. The CHMP's decision follows a re-examination procedure and is a significant step towards the approval of lecanemab in the European Union.

Lecanemab is intended for the treatment of adult patients with a clinical diagnosis of mild cognitive impairment and mild dementia due to Alzheimer's disease (early Alzheimer's disease) who are apolipoprotein E ε4 (ApoE ε4) non-carriers or heterozygotes with confirmed amyloid pathology. The drug has already been approved in several countries, including the United States, Japan, and China.

The CHMP's positive opinion is based on the results of the Clarity AD clinical trial, which demonstrated the efficacy and safety of lecanemab in patients with early Alzheimer's disease. The trial showed that lecanemab reduced clinical decline on the Clinical Dementia Rating-Sum of Boxes (CDR-SB) by 33% at 18 months compared to placebo in the recommended indicated population (ApoE ε4 heterozygotes or non-carriers). Additionally, the secondary endpoint from the AD Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS-MCI-ADL) noted 39% less decline compared to placebo at 18 months.

The safety profile of lecanemab was considered acceptable, with infusion-related reactions occurring in 26.4% of participants and amyloid-related imaging abnormalities with edema or effusions in 12.6%. The CHMP likely considered the benefit of the treatment to outweigh the risks for the patient population in question.

The reaffirmed positive opinion from the CHMP is a positive development for Eisai and Biogen, as it brings lecanemab one step closer to approval in the European Union. The drug has the potential to address an unmet need in the treatment of early Alzheimer's disease and reduce the overall burden on people affected by AD and society.