News Release

AstraZeneca seeks mania indication for Seroquel in Europe

Business Announcement

Shire Health International

Sodertalje, Sweden – AstraZeneca announced today that it has submitted an application to the 14 European Member States involved in the Mutual Recognition Procedure for Seroquel (quetiapine) to be granted a licence for the treatment of manic episodes associated with bipolar disorder (manic-depressive illness). The Type II licence variation application to Seroquel's existing schizophrenia marketing authorisation means that the drug is now currently under regulatory review for bipolar mania both in Europe and the United States (1).

"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 programme undertaken by AstraZeneca to examine the efficacy and tolerability of Seroquel in this important disease area. The programme 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 programme consisted of four double-blind, randomised 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 stabiliser 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" commented 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 over 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 favourable weight profile, and no clinically important effects on QT interval in most patients. To date, over 4 million people have been treated with Seroquel worldwide.

AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the top five pharmaceutical companies in the world with healthcare sales of over $16.4 billion and leading positions in sales of gastrointestinal, oncology, anaesthesia (including pain management), cardiovascular, central nervous system (CNS) and respiratory products. In CNS, AstraZeneca is dedicated to providing medicines that offer the potential to change patients' lives. The company already markets Seroquel, one of the fastest growing global antipsychotics with proven efficacy and a very favourable side effect profile; and Zomig, a reliable migraine therapy and a leader in the triptan market. AstraZeneca's R&D pipeline also includes leading approaches for the treatment of depression and anxiety, overactive bladder, dementia and stroke.


Notes to editors:
Results from one of the adjunct trials were presented earlier this year at the 3rd European Stanley Foundation Conference in Bipolar Disorder, in Germany (2). The results from this three-week trial showed that Seroquel (average dose in responders of 580 mg/day), in combination with a standard mood stabilising medication (lithium or divalproex), is significantly more effective than mood stabilisers alone in treating manic episodes and is also well tolerated. Specifically, the results showed that patients treated with Seroquel plus mood stabilizer benefited from:

  • a significantly greater improvement from baseline in their Young Mania Rating Scale (YMRS) total scores at day 21 compared with patients taking mood stabilizers alone (-13.76 and -9.93 respectively, p=0.021).
  • a significantly greater improvement from baseline in their Clinical Global Impression Bipolar (CGI-BP) Severity of Illness scores at endpoint compared to patients taking mood stabilizer alone (-1.38 and -0.78 respectively, p=0.001).
  • an incidence of EPS no different from placebo across the full dose range.

The results from the remaining monotherapy studies will be presented at major psychiatry conferences in 2003.

'Seroquel' is a trade mark property of AstraZeneca.

For further information, please contact:

Jim Minnick at AstraZeneca
Tel: 302-886-5135


Rupert Doggett at Shire Health International
Tel. 44-207-471-1500

This psychiatry resource features educational materials relating to severe mental illness, including background information on schizophrenia as well as epidemiological data and treatment issues clinicians face in everyday practice.

1. AstraZeneca submitted an application to the U.S. Food and Drug Administration (FDA) for quetiapine (Seroquel) to be granted a license for the treatment of acute mania associated with bipolar disorder (manic-depressive illness) on December 30th, 2002.
2. Sachs G, Mullen JA, Devine NA. Quetiapine vs Placebo as Adjunct to Mood Stabilizer for the treatment of acute mania. Stanley Foundation Bipolar Conference, 2002, abs.

Disclaimer: AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert system.