AstraZeneca submits Seroquel in Europe for bipolar conditions

AstraZeneca has submitted Seroquel XR (quetiapine fumarate) extended release tablets for the treatment of bipolar mania and bipolar depression and Seroquel for the treatment of bipolar depression in the EU.

Included in this European submission is data from the Embolden study programme which involved 1,542 patients and the Bolder study programme.

Data from the Embolden studies, which encompassed an initial treatment period of eight weeks and a 52-week treatment continuation phase, will be published in the coming months.

Seroquel XR is currently approved in a number of European countries for both acute and maintenance treatment of schizophrenia in adults.

“Estimates indicate up to five per cent of people worldwide will suffer from bipolar disorder at some point in their lives, reducing quality of life substantially and posing a risk of self-harm and suicide,” AstraZeneca reports.

The firm approximates that Seroquel has been prescribed to over 25 million patients worldwide since its launch in 1997.

AstraZeneca reports that planned future regulator filings for the compound include those for major depressive disorder and generalised anxiety disorder.

In February 2007, AstraZeneca was sued by nearly 10,000 patients who used Seroquel who claimed that the firm had not sufficiently warned of severe adverse effects, including weight gain, Bloomberg reports.

The news agency added that AstraZeneca rejected these claims and would defend itself against them.