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Eisai and Biogen Japan Collaborate with NCNP for APOE Genetic Testing in Alzheimer’s Research

NextEdge Admin

27 Nov 2024

2 min 37 sec

Biogen Japan Ltd.,Psychiatry,Neurology,LEQEMBI®

Eisai Co., Ltd. and Biogen Japan Ltd. announced a research collaboration with the National Center of Neurology and Psychiatry (NCNP) to conduct APOE genetic testing as part of the dementia research program, “Development and Analysis of a National Clinical Registry of Disease-Modifying Therapies for Alzheimer’s Disease” (AD-DMT Registry). This program is supported by the Japan Agency for Medical Research and Development (AMED), with NCNP leading the initiative.

The APOE gene is a known risk factor for Alzheimer’s disease and is associated with amyloid-related imaging abnormalities (ARIA) observed in anti-amyloid β antibody treatments like lecanemab (LEQEMBI®). Since APOE genetic testing is not yet covered under Japan’s National Health Insurance, Eisai will fund the testing within the AD-DMT Registry to study the APOE genotype’s impact on the safety and efficacy of lecanemab.

Data collected will contribute to a broader understanding of the relationship between APOE genotypes and Alzheimer’s treatments. This research complements lecanemab-specific post-marketing surveillance and will support the reexamination of lecanemab’s application by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, ensuring the treatment aligns with the latest scientific insights.

The AD-DMT Registry, led by NCNP, aims to collect clinical data from routine care, evaluate the efficacy and safety of anti-amyloid β drugs, and perform APOE genotyping alongside biomarker analysis. Findings will be shared with participating patients, enhancing understanding of drug outcomes based on genetic profiles.

Through this collaboration, Eisai and Biogen Japan are advancing Alzheimer’s disease treatment and improving patient care. Eisai leads lecanemab’s global development and co-commercializes it with Biogen, with Eisai also acting as the Marketing Authorization Holder in Japan.