Astellas files for approval of extended-release quetiapine in Japan

10 August 2016

Japanese drug major Astellas Pharma (TYO: 4503) has submitted a new drug application to the Ministry of Health, Labor and Welfare in Japan for extended-release tablets of quetiapine fumarate (FK949E) for the indication of improvement of depressive symptoms associated with bipolar disorder.

Astellas has a license agreement with Anglo-Swedish peer AstraZeneca (LSE: AZN) that provides it with exclusive rights in Japan to develop and commercialize extended-release tablets of quetiapine fumarate, AstraZeneca’s now off-patent once-daily blockbuster drug Seroquel XR.

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.

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