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AZ submits two sNDAs for Seroquel XR

AstraZeneca submits two separate supplemental sNDAs to the FDA for its once-daily Seroquel XR extended-release tablets

UK-based AstraZeneca (AZ) has submitted two separate supplemental New Drug Applications (sNDAs) to the FDA for its once-daily Seroquel XR (quetiapine) extended-release tablets.

The sNDA seeks approval for the treatment of manic episodes associated with bipolar disorder and the treatment of depressive episodes associated with bipolar disorder.

The bipolar mania submission was based on a clinical study of once-daily treatment with Seroquel XR, compared with placebo, with a primary endpoint of change in Young Mania Rating Scale (YMRS) total score in 316 patients suffering from bipolar mania.

The bipolar depression submission was supported by a clinical study of once-daily treatment with Seroquel XR, compared to placebo, with a primary endpoint of change from baseline in Montgomery Asberg Depression Rating Scale (MADRS) total score after eight weeks of treatment, in 280 patients diagnosed with bipolar depression.

Doses of Seroquel XR administered in both the bipolar mania (400 mg to 800 mg/day) and bipolar depression (300 mg/day) studies were comparable with the FDA-approved recommended doses for immediate release tablets in those indications.

Both studies met their primary endpoint and it is expected that they will be presented at major scientific meetings in 2008.

Seroquel XR is currently approved in eight countries including the US, Canada and the Netherlands, for the acute and maintenance treatment of schizophrenia in adults.

Global sales of Seroquel for the first nine months of 2007 were USD 2.9bn, an increase of 15 per cent on the same period of 2006 for AZ.

3rd January 2008


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