Seroquel XR and Seroquel approved in Europe

Once-daily Seroquel XR (quetiapine fumarate extended-release tablets) and Seroquel (quetiapine fumarate) have been approved under the European Mutual Recognition Procedure for the treatment of bipolar disorder.

The drugs have been approved specifically to prevent the 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 EU 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 has said that it will now move forward to obtaining local approvals with the Member States that take part in the Mutual Recognition Procedure.

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.

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).

It is estimated that the worldwide prevalence of bipolar disorder is 3–5 per cent.