Seroquel XR and Seroquel Approved in Europe for Prevention of Recurrence of Bipolar Disorder

Tuesday, 29 September 2009

AstraZeneca announced today that once-daily SEROQUEL XR (quetiapine fumarate extended-release tablets) and SEROQUEL (quetiapine fumarate) have been approved under the European Mutual Recognition Procedure for the prevention of recurrence of bipolar disorder in patients whose manic, mixed or depressive episode has responded to quetiapine treatment.

Following this new indication, SEROQUEL and SEROQUEL XR are the only agents approved in the European Union to treat all phases of bipolar disorder – acute depressive episodes, acute manic episodes and maintenance treatment to prevent recurrence of any mood event in bipolar disorder.

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


About Bipolar Disorder

Bipolar disorder is a 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 episodes 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 percent.

Bipolar disorder is often misdiagnosed as unipolar depression. This misdiagnosis can lead to treatment that may exacerbate the disease. In fact, many patients face up to ten years without appropriate treatment before a correct diagnosis is made. Bipolar disorder is typically managed through a treatment strategy with several phases – including acute and maintenance phases. In the acute phase, the aim is to improve the acute symptoms of the patient; the maintenance treatment phase aims to reduce the risk of recurrence of future episodes.


SEROQUEL XR has been approved in 63 countries for schizophrenia, 38 countries for bipolar mania, in 37 countries for bipolar depression, in 9 markets for bipolar maintenance, in 1 market for Generalised Anxiety Disorder (GAD), and in 3 markets for Major Depressive Disorder (MDD), with Canada receiving approval of MDD in May 2009.

In May 2009, AstraZeneca referred an application for SEROQUEL XR in the treatment of Major Depressive Disorder (MDD) to the EU Committee for Medicinal Products for Human Use (CHMP) for arbitration. This followed a negative outcome for the application in the Mutual Recognition Procedure. An application for SEROQUEL XR in the treatment of MDD was also filed with the US FDA in February 2008. These applications remain under review by the regulatory authorities.

Launched in 1997, SEROQUEL (quetiapine fumarate) has been approved in 94 countries for schizophrenia, 91 countries for bipolar mania, in 51 countries for bipolar depression and in 8 countries for bipolar maintenance.

MRP Countries

AstraZeneca will move forward with obtaining local approvals for the prevention of recurrence of bipolar disorder in patients whose manic, mixed or depressive episode has responded to quetiapine treatment in the following EU Member States: Austria, Belgium, Cyprus, Denmark, Finland, Germany, Greece, Iceland, Ireland, Luxembourg, the Netherlands, Norway, Malta, Portugal, Poland, Spain and Sweden.

About AstraZeneca
AstraZeneca is a major international healthcare business engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US$ 31.6 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines. For more information about AstraZeneca, please visit:


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