Mania indication sought for Seroquel in Europe - Bipolar Disorder

06 марта, 2003
AstraZeneca has submitted an application to the 14 European Member States involved in the Mutual Recognition Procedure for Seroquel to be granted a license for the treatment of manic episodes associated with bipolar disorder . Medical Letter on the CDC & FDA via NewsEdge Corporation : AstraZeneca has submitted an application to the 14 European Member States involved in the Mutual Recognition Procedure for Seroquel (quetiapine) to be granted a license for the treatment of manic episodes associated with bipolar disorder (manic-depressive illness). The Type II license variation application to Seroquel's existing schizophrenia marketing authorization means that the drug is now currently under regulatory review for bipolar mania both in Europe and the United States. "We are delighted to be submitting our application to the European health authorities so soon after our submission to the FDA" commented Geoff Birkett, global vice president, CNS, pain and infection. "Seroquel is a truly unique compound and its profile is ideal for the treatment of manic episodes associated with bipolar disorder. Use of Seroquel has been growing at a tremendous rate in Europe and feedback from patients and clinicians continues to be very positive. With its expanded indication range we are sure of further strong growth in 2003 and beyond." The application to the European health authorities follows the completion of a comprehensive bipolar disorder clinical trial program undertaken by AstraZeneca to examine the efficacy and tolerability of Seroquel in this important disease area. The program has delivered strong and positive results in both monotherapy and adjunctive therapy studies, which confirm Seroquel to be an ideal first-line agent in the treatment of manic episodes associated with bipolar disorder. The trial program consisted of four double-blind, randomized trials, involving almost 1000 patients in 28 countries. The trials assessed the effectiveness and safety of Seroquel as both monotherapy and adjunctive therapy with mood stabilizer in the treatment of manic episodes associated with bipolar disorder. "Seroquel as a treatment for bipolar disorder will offer significant benefits to European clinicians and patients," said Dr. Eduard Vieta, director of research, department of psychiatry, University of Barcelona. "Throughout the duration of the studies, Seroquel was shown to provide a substantial resolution of the various symptoms associated with manic episodes, while keeping side effects to a minimum. This is particularly critical in bipolar disorder since patients may lead full and productive lives when stable while a relapse in symptoms can cause real difficulties." Seroquel has been simultaneously submitted to the 14 European Member States participating in the Mutual Recognition Procedure. Further submissions in other markets worldwide are progressing. Seroquel is manufactured by AstraZeneca and is currently approved in more than 75 markets. Seroquel combines broad-based efficacy in the treatment of positive, negative, cognitive and affective symptoms of schizophrenia, while offering excellent tolerability. Seroquel is associated with an incidence of EPS and prolactin elevation no different to placebo across the full dosage range, a favorable weight profile, and no clinically important effects on QT interval in most patients. This article was prepared by Medical Letter on the CDC & FDA editors from staff and other reports. <> << Copyright ©2003 NewsRx.com >>
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