"This approval is great news for clinicians involved in the treatment of bipolar disorder," commented Dr. Eduard Vieta, Director of Research, Department of Psychiatry, University of Barcelona. "The results from the clinical trial programme confirm that SEROQUEL™ holds real benefits for clinicians looking to treat the symptoms of the disease while keeping side effects to a minimum. This is of particular importance when treating patients with bipolar disorder since they can be particularly sensitive to treatment side effects which can in turn have a negative impact on compliance with medication."
Bipolar disorder is a serious mental illness that affects approximately 3-4% of the adult population and is the sixth leading cause of disability in the world.1,2,3,4 More than half of those with bipolar disorder stop taking their medication at some point during their illness, subjecting themselves to a high risk of relapse and an increased risk of suicide.5 This lack of compliance is strongly associated with the occurrence of side effects, therefore, a well tolerated and effective treatment is pivotal to the successful treatment of this condition.
Health authorities involved in the Mutual Recognition Procedure reviewed data from a comprehensive clinical trial programme in bipolar disorder undertaken by AstraZeneca, involving almost 1000 patients in 28 countries. The trials have delivered compelling results which confirm SEROQUEL™ to be an excellent first line therapy for the treatment of manic episodes associated with bipolar disorder.
Individual licenses in the 14 European countries involved in the MRP will follow from the completion of this procedure. Health Authority approvals have also been received in Mexico and New Zealand.
"We believe that SEROQUEL™ is an outstanding treatment which has benefited many patients who suffer from schizophrenia - and we are committed to further developing the product in the future," commented Geoff Birkett, Vice President, Global Marketing Neuroscience, AstraZeneca. "Our belief is that the clinical profile of SEROQUEL™ in bipolar mania is extremely well suited to this new patient group who place high demands on their therapy and need a balance of strong efficacy with enhanced tolerability. We have very high expectations for SEROQUEL™ as we launch into this competitive market and have set our sights on raising treatment standards in the area."
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 $17.8 billion and leading positions in sales of gastrointestinal, oncology, cardiovascular, neuroscience and respiratory products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global and European) as well as the FTSE4Good Index.
In Neuroscience, AstraZeneca is dedicated to providing medicines that have the potential to change patients' lives. The company already markets several products including SEROQUEL™, one of the fastest growing global antipsychotics with proven efficacy and a very favourable side effect profile; and ZOMIGä, a reliable migraine therapy and a leader within the triptan market. The Neuroscience pipeline includes leading approaches for the treatment of depression and anxiety, overactive bladder, dementia and stroke, pain control and anaesthesia.
For more information, please visit www.astrazenecapressoffice.com
Notes to Editors
All product names appear in upper case. SEROQUEL™ is a trade mark of the AstraZeneca group of companies
For further information, please contact:
Jim Minnick at AstraZeneca
Tel: +1 302 886 5135
jim.minnick@astrazeneca.com
or
Rupert Doggett at Shire Health International
Tel: +44 (0)207 471 1500
rupert.doggett@shirehealthinternational.com
For an electronic and downloadable version of this press release or for further information about SEROQUEL™, please visit the psychiatry resource internet site at: www.psychiatry-in-practice.com 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.
References:
1 American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision. Washington DC, American Psychiatric Association, 2000:385, 395.
2 Hirschfield et al. J Clin Psychiatry. 2003;64:53-59
3Lisd JD, Dime-Meenan S, Whybrow PC et al. The National Depressive and Manic-Depressive Association (DMDA) survey of bipolar members. J Affect Disord. 1994;31:281-294.
4 World Health Organization and the World Bank. The Global Burden of Disease: Summary. Cambridge, Mass: The Harvard School of Public Health Harvard University Press, 1996.
5 Miklowitz D. The Bipolar Disorder Survival Guide. New York: The Guilford Press, 2002.