Tokyo, August 9, 2016 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, “Astellas”) today announced that it submitted a new drug application to the Ministry of Health, Labour and Welfare in Japan for extended-release tablets of quetiapine fumarate (generic name, Code No.: FK949E) for the indication of improvement of depressive symptoms associated with bipolar disorder. Astellas has a license agreement with AstraZeneca UK Ltd. (LSE: AZN, headquarters: the United Kingdom, CEO: Pascal Soriot) that provides Astellas exclusive rights to develop and commercialize extended-release tablets of quetiapine fumarate in Japan.
This application is based primarily on the results of a Phase-III clinical trial consisting of a placebo-controlled, double-blind, comparative study and an extension study, to confirm the efficacy and safety of extended-release tablets of quetiapine fumarate, administered orally once daily to Japanese patients diagnosed with bipolar depression. The program started following a development request from the Evaluation Committee on Unapproved or Off-label Drugs with High Medical Needs.
Astellas expects this new drug application will provide an additional therapeutic option to patients diagnosed with bipolar depression, and thus will make a contribution to treatment of neuropsychiatric disorders.
This submission in Japan has no impact on Astellas’ financial results for the fiscal year ending March 31, 2017.