Eisai signs research collaboration agreement with the National Center of Neurology & Psychiatry to initiate apolipoprotein E genetic testing in the AD-DMT Registry in Japan

The research will be implemented by the Japan Agency for Medical Research and Development (AMED), with NCNP as the lead research institution. The APOE gene is known to be a risk factor for the onset of Alzheimer’s disease and is also associated with the frequency of amyloid-related imaging abnormalities (ARIA) in anti-amyloid beta antibody treatments such as lecanemab (Leqembi). In Japan, at present, APOE genetic testing is not available for routine clinical practice under National Health Insurance. For this reason, by using APOE genetic information collected in the AD-DMT Registry, Eisai and NCNP can further study the relationship between the APOE genotype and the safety and efficacy of treatment with lecanemab. Based on this research collaboration agreement with NCNP, Eisai will cover the cost of the APOE genetic testing conducted in the AD-DMT Registry. The findings, along with data collected from the lecanemab-specific post-marketing surveillance (all-case surveillance), will be part of the reexamination of lecanemab’s application by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) to ensure the label reflects the latest scientific understanding with the goal of improving patient outcomes. Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen Inc. (U.S.) co-commercializing and co-promoting the product and Eisai having final decision-making authority. In Japan, Eisai and Biogen Japan will co-promote lecanemab, with Eisai distributing the product as the Marketing Authorization Holder.