Regulatory Approval

RNS Number : 0716I

AstraZeneca PLC

13 November 2008

 



SEROQUEL XR and SEROQUEL approved in Europe for new indications for the treatment of bipolar disorder

AstraZeneca today announced that the once-daily formulation SEROQUEL XR (quetiapine fumarate extended release tablets) and SEROQUEL (quetiapine fumarate) have been approved under the European Mutual Recognition Procedure (MRP) for new indications in bipolar disorder. SEROQUEL XR and SEROQUEL have been approved for the treatment of major depressive episodes in bipolar disorder. Additionally, SEROQUEL XR has been licensed for moderate to severe manic episodes in bipolar disorder. 

This follows the October 2008 approval of SEROQUEL XR in similar indications by the US Food and Drug Administration (FDA). As a result of these new indications for adult patients, SEROQUEL (both formulations) is currently the only atypical antipsychotic approved to treat the spectrum of mood episodes associated with bipolar disorder and the only licensed treatment for bipolar depression in the EU.  The mechanism of action of SEROQUEL, which involves both antipsychotic and antidepressant activities, may help explain its unique efficacy across the spectrum of mood episodes associated with bipolar disorder.

AstraZeneca will move forward with obtaining local approvals with the 17 Member States that take part in the Mutual Recognition Procedure.

About bipolar disorder

Bipolar disorder is a common and serious mental illness that causes dramatic and severe mood swings. Bipolar I disorder is the classic form of the disease, characterised by recurrent episodes of mania and depression. Bipolar II disorder involves one or more periods of major depression with at least one episode of mild to moderate mania (hypomania), but never full mania.  It is estimated that the worldwide prevalence of bipolar disorder is 3-5%.  Up to half of all individuals with bipolar disorder make at least one suicide attempt in their lifetime, and approximately 10-15% complete suicide. Currently, there is no licensed treatment for bipolar depression in the EU, making this approval a significant step forward for clinicians and patients.

About SEROQUEL XR and SEROQUEL

SEROQUEL XR has been approved in 43 countries for schizophrenia (including all 17 countries in the Mutual Recognition Procedure), 12 countries for bipolar mania, in 7 countries for bipolar depression, in 3 markets for bipolar maintenance, in 1 market for Major Depressive Disorder (MDD), and in 1 market for Generalised Anxiety Disorder (GAD). 

A filing for SEROQUEL XR seeking approval for the treatment of MDD was made in the US in February this year with the EU filing in June. In October 2008, SEROQUEL XR became the first atypical antipsychotic to be filed with the EMEA in Europe seeking approval for the treatment of GAD. A similar filing was made to the FDA in May 2008. These applications remain under review by the regulatory authorities.

Launched in 1997, it is estimated that SEROQUEL has been prescribed to more than 22 million patients worldwide*. It is approved in 92 countries for the treatment of schizophrenia, in 88 countries for the treatment of bipolar mania, and in 30 countries including the US for the treatment of bipolar depression.

*Estimates based on IMS APLD and Prescription data.

MRP countries

AstraZeneca will move forward with obtaining local approvals for bipolar indications in the following EU Member States: Austria, Belgium, Cyprus (XR only), Denmark, Finland, Germany, Greece, Iceland, Ireland, Luxembourg, the Netherlands, Norway, Malta (XR only), Portugal, Poland (XR only), Spain and Sweden.

About 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 billion 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. For more information please visit: www.astrazeneca.com

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13 November 2008

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