On November 26, 2024, Eisai Co., Ltd. and Biogen Japan Ltd. announced a research collaboration agreement with the National Center of Neurology and Psychiatry (NCNP) in Japan. This collaboration aims to initiate apolipoprotein E (APOE) genetic testing within the 'Development and Analysis of a National Clinical Registry of Disease-Modifying Therapies for Alzheimer's Disease' (AD-DMT Registry).
Eisai will cover the cost of the APOE genetic testing conducted in the AD-DMT Registry. The APOE gene is recognized as a risk factor for Alzheimer's disease onset and is associated with the frequency of amyloid-related imaging abnormalities (ARIA) in anti-amyloid β antibody treatments like lecanemab (LEQEMBI). Currently, APOE genetic testing is not routinely available under Japan's National Health Insurance.
The research will utilize APOE genetic information from the AD-DMT Registry to further study the relationship between APOE genotype and the safety and efficacy of lecanemab treatment. The findings, combined with data from lecanemab-specific post-marketing surveillance, will contribute to the reexamination of lecanemab's application by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), with the goal of ensuring the label reflects the latest scientific understanding and improving patient outcomes.
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