Bipolar Depression Licence Application For Seroquel(R)

Main Category: Bipolar
Also Included In: Regulatory Affairs / Drug Approvals;  Schizophrenia
Article Date: 18 Feb 2008 - 1:00 PDT

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AstraZeneca has submitted an application to the Medicines and Healthcare products Regulatory Agency (MHRA) for a new licence for Seroquel(R) (quetiapine fumarate) in the UK for major depressive episodes in the framework of bipolar disorder.

Quetiapine is currently licensed in the UK for the treatment of schizophrenia and manic episodes associated with bipolar disorder.1

Bipolar disorder affects about one in every 100 adults at some point in their life.2 In some cases, it can take many years to receive a diagnosis and this can have a large impact on a patient's recovery. Tragically approximately 10 to 15 per cent of people suffering from bipolar disorder will take their own lives5,±.

The new licence submission for use in bipolar depression is based on data from the BOLDER I and II (BipOLar DEpRession) studies.3,4 These data suggested quetiapine was effective and well tolerated as monotherapy in the treatment of depressive episodes in bipolar disorder.

"The impact of having a manic or depressive episode for patients with bipolar disorder can be very serious.2 If the application is successful, Seroquel will be the first atypical antipsychotic to be licensed for monotherapy treatment of both mania & depression in bipolar disorder in the UK. We look forward to hearing the results of the license submission soon." Mathew Crowther, AstraZeneca Regulatory Team Manager

±Lifetime risk

The Seroquel SmPC is available on request or can be found at http://emc.medicines.org.uk/

Seroquel

Launched in 1997, it is estimated that Seroquel has been prescribed to more than 25 million** patients worldwide. Seroquel is approved in 88 countries for the treatment of schizophrenia, in 77 countries for the treatment of bipolar mania, and in 11 countries including the US for the treatment of bipolar depression.

AstraZeneca

AstraZeneca is a major international healthcare business engaged in research, development, manufacturing and marketing of prescription pharmaceuticals and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US $29.55 billion6 and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection product sales. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.

** This estimate is based upon: (1) assumptions as to persistence (the number of prescriptions per patient) based upon 2002 market research; and (2) projections of prescriptions since launch based upon information available in the US and 13 of the 50 other countries in which SEROQUEL is marketed.

References

1. Seroquel (quetiapine fumarate) Summary of Product Characteristics. November 2007

2. Royal College of Physicians. ' Bipolar disorder (manic depression)' (Accessed January 2008)

3. Calabrese JR, Keck PE, Macfadden W, et al, for the BOLDER Study Group. A randomized, double-blind, placebo-controlled trial of quetiapine in the treatment of bipolar I or II depression. Am J Psychiatry 2005;162;1351-1360.

4. Thase M, McCoy R, Chang W, Macfadden W. Efficacy of quetiapine monotherapy in bipolar depression: a confirmatory double-blind, placebo controlled study (the BOLDER II Study). Presented at the American Psychiatric Association Annual Meeting, Toronto, 2006. (Abstract)

5. Hawton K et al. Suicide and attempted suicide in bipolar disorder: A systematic review of risk factors. J Clin Psych 2005;66:693-704

6. AstraZeneca 2007 full year financial report

AstraZeneca