AstraZeneca files for new Seroquel indication in EU

Anglo-Swedish drug major AstraZeneca has submitted applications in the European Union under the Mutual Recognition Procedure for once-daily Seroquel XR (quetiapine fumarate) extended-release tablets, seeking approval for the treatment of manic episodes associated with bipolar disorder and depressive episodes associated with this condition. This follows two supplemental New Drug Applications to the US Food and Drug Administration, announced in January, for the same indications.

The UK-based firm also filed a further application in the EU for Seroquel immediate release, for the treatment of bipolar depression, an indication approved in the USA in October 2006. In addition to data from the BOLDER study program, the European submission includes new data from the EMBOLDEN study. 1,542 patients were randomized into the latter, which included a 52-week treatment continuation phase following an initial treatment period of eight weeks. The data will be published in full over the coming months.

Estimates indicate up to 5% 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.