Seroquel and Seroquel XR approved for new indications in bipolar disorder in EU

Friday 14 November 2008
Katie McQue - Reporter

AstraZeneca's antipsychotic Seroquel (quetiapine fumarate) and the once-a-day extended release formulation, Seroquel XR, have received approval for the treatment of major depressive episodes in bipolar disorder via the European mutual recognition procedure (MRP). Additionally, Seroquel XR has been licensed for moderate to severe manic episodes in bipolar disorder.

Seroquel (both formulations) is the only atypical antipsychotic licensed for the treatment of bipolar depression in the EU.

The decision under the MRP follows Seroquel XR's US FDA approval for treatment of bipolar depression and mania (Scrip Online, October 14th, 2008).

Launched in 1997 and 2007, respectively, Seroquel and Seroquel XR were initially indicated for schizophrenia.

In the US, Seroquel (original formulation) has been approved since 2004 for depressive episodes associated with bipolar disorder and as either a monotherapy or adjunct therapy for acute manic episodes associated with bipolar I disorder.

A filing seeking approval for Seroquel XR in the treatment of generalised anxiety disorder was submitted in the US in May and in the EU in October (Scrip Online, May 16th, 2008).

Filings for approval of Seroquel XR in treatment of major depressive disorder were made in the US in February and in the EU in June (Scrip Online, June 18th, 2008).

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