Kissei Pharmaceutical Co. Ltd. has withdrawn its NDA in Japan for rovatirelin (KPS-0373) for the treatment of spinocerebellar degeneration. Kissei, of Osaka, Japan, said it temporarily withdrew the application for marketing approval and would discuss the possibility of conducting additional clinical trials with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), because the PMDA expressed concern about the approval based on the current clinical trial data.