Astra Zeneca seeks EU approval for Seroquel in manic depression.

15 февраля, 2003
Astra Zeneca has submitted an application for registration of Seroquel in 14 EU member states which participate in the mutual approvals procedure. Chemical Business NewsBase - Dagens Industri via NewsEdge Corporation : Astra Zeneca has submitted an application for registration of Seroquel (quetiapin) in 14 EU member states which participate in the mutual approvals procedure. The application is for an extension of the approval to include the treatment of manic episodes in manic depression and is based on a comprehensive programme of clinical studies in manic depressive patients aimed at determining efficacy and tolerance. The results from the study indicate that Seroquel has a pronounced positive effect both as a single therapy and in combination with other drugs (lithium or divalproex) and support the claim that Seroquel is an excellent treatment of first choice. Applications for extended approval are planned for other markets throughout the world. At present Seroquel is only approved for the treatment of schizophrenia in adults. The market for treatment of manic depression is estimated at several billions of US dollars. Seroquel is the fastest growing atypical antipsychotic on the market, with global sales of $1.1 bn in 2002. Publication: Chemical Business NewsBase - Dagens Industri Distributed by Financial Times Information Limited - Asia Africa Intelligence Wire <> << Copyright ©2003 Financial Times Limited, All Rights Reserved >>