TOKYO—Eisai Co. Ltd. announced recently that its U.S. subsidiary Eisai Inc. has bought out Purdue Pharma L.P.'s rights in the worldwide collaboration for the development and commercialization of lemborexant, an investigational sleep-wake regulation agent being studied for the treatment of multiple sleep-wake disorders, including insomnia and irregular sleep-wake rhythm disorder (ISWRD) in patients with Alzheimer's disease. Eisai Group will solely conduct the development and the commercialization of lemborexant globally.
Discovered by Eisai, lemborexant is an investigational dual orexin receptor antagonist. The U.S. Food and Drug Administration accepted the New Drug Application for lemborexant for use in the treatment of insomnia disorders for review in March, and set a Prescription Drug User Fee Act date for Dec. 27, 2019.
For Japan, a marketing authorization application for lemborexant for use in the treatment of insomnia disorder had been submitted to the Pharmaceuticals and Medical Devices Agency in March, and is currently under review. Furthermore, a Phase 2 clinical study of lemborexant for ISWRD in patients with Alzheimer's disease is ongoing.
Through lemborexant, Eisai is striving to address unmet medical needs and contribute to further increasing the benefits for patients with sleep disorders and their families.