Eisai Co., Ltd. and Biogen Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a negative opinion on the Marketing Authorization Approval (MAA) for lecanemab, their humanized anti-amyloid-beta monoclonal antibody. Lecanemab is intended for early-stage Alzheimer’s disease (AD), targeting mild cognitive impairment and mild AD.
Despite its approval in the United States, Japan, China, South Korea, Hong Kong, and Israel, the rejection from EMA poses a significant setback for Eisai and Biogen. Eisai plans to seek re-examination and is committed to ensuring that this treatment becomes available to eligible patients in the European Union.
Lecanemab’s global development and regulatory submissions are led by Eisai, with both companies co-commercializing the product. The drug showed promise in Eisai’s Phase 3 Clarity AD clinical trial, meeting its primary and all key secondary endpoints. Results indicated a 27% reduction in clinical decline on the Clinical Dementia Rating Sum of Boxes (CDR-SB) at 18 months compared to a placebo.
The prevalence of Alzheimer’s in Europe, currently affecting 6.9 million people, underscores the urgent need for innovative treatments. Eisai’s commitment to addressing this unmet need continues, despite the CHMP’s current stance. Future regulatory submissions and trials will determine the broader accessibility of lecanemab for Alzheimer’s patients globally.
