Kissei Pharmaceutical Co., Ltd. announced the withdrawal of application for marketing approval in Japan for Rovatirelin (generic name, development number: KPS-0373), a treatment for spinocerebellar degeneration, in order to consider the future development strategies. Based on the results of two Phase III clinical trials and a combined analysis conducted to date, company determined that Rovatirelin was the first drug which has been verified to be effective to improve ataxia in patients with spinocerebellar degeneration assessed with international SARA score. The company submitted an application for marketing approval on December 22, 2021*.

However, Kissei decided to temporarily withdraw the application for marketing approval and discuss the possibility of conducting additional clinical trials with the Pharmaceuticals and Medical Devices Agency (PMDA), because the PMDA has recently expressed its opinion that the marketing approval based on the current clinical trial data would be difficult. The impact of this matter on this fiscal year's business performance is minimal. If any matters requiring disclosure arise in the future, they will be promptly announced.