This article has been updated with additional information about the Japanese label for Leqembi and the duration of the reexamination period.
NEW YORK – Eisai on Tuesday said it has struck a research collaboration agreement with the National Center of Neurology and Psychiatry (NCNP), a healthcare and research organization in Tokyo, to conduct APOE genetic testing as part of a dementia research program.
The Japan Agency for Medical Research and Development, which is an independent R&D organization overseen by the Japanese government, will implement the program, which is dubbed the Development and Analysis of a National Clinical Registry of Disease-Modifying Therapies for Alzheimer's Disease, abbreviated as the AD-DMT Registry. NCNP will serve as the lead research institution.
The APOE ε4 allele is a risk factor for Alzheimer's disease and has been associated with amyloid-related imaging abnormalities (ARIA), a typically asymptomatic, but sometimes fatal, adverse event that's been observed in patients taking beta-amyloid-targeting drugs such as Eisai and Biogen's Leqembi (lecanemab).
Patients with two copies of the APOE ε4 allele, in particular, are known to be at high risk for ARIA, which can present as temporary swelling or bleeding in the brain.
In the US, the Food and Drug Administration required boxed warnings on the labels for Leqembi and its competitor in the anti-amyloid Alzheimer's treatment market, Eli Lilly's Kisunla (donanemab), recommending genetic testing for patients before beginning treatment with the drugs to provide information on a patient's risk of developing ARIA.
However, in Japan, APOE genetic testing is not available as part of routine clinical practice through national health insurance. The Japanese label for Leqembi specifies that information should be provided to patients, families, and caregivers about the "occurrence rate of ARIA due to this drug, the risk of ARIA, tests necessary for risk management, and measures to be taken when ARIA occurs," an Eisai spokesperson said in an email.
Eisai, which is headquartered in Tokyo, will cover the cost of APOE genetic testing conducted within the AD-DMT Registry. Eisai and NCNP plan to use this data to study the relationship between APOE genotype and the safety and efficacy of treatment with Leqembi, which was approved in Japan in September 2023.
These findings, alongside other data collected from post-marketing surveillance, will be considered as part of the reexamination of Leqembi's application by the Japanese Pharmaceuticals and Medical Devices Agency. The agency establishes a reexamination period for post-marketing surveillance of drugs after they're approved in the country to confirm efficacy and safety.
The reexamination period for Leqembi, as a drug with new active ingredients, is eight years, a company spokesperson said in an email.