AstraZeneca announced that the company has submitted applications in the European Union (EU) under the Mutual Recognition Procedure (MRP) for once-daily SEROQUEL XR(TM) (quetiapine fumarate) Extended-Release Tablets, seeking approval for the treatment of manic episodes associated with bipolar disorder and the treatment of depressive episodes associated with bipolar disorder. This follows two supplemental New Drug Applications (sNDAs) to the U.S. Food and Drug Administration (FDA), announced in January, for the same indications.
AstraZeneca also announced it has submitted a further application in the EU for SEROQUEL® (quetiapine fumarate immediate release, IR) for the treatment of bipolar depression, an indication approved in the US by the FDA in October 2006. In addition to data from the BOLDER study programme, the European submission includes new data from the EMBOLDEN study programme. 1,542 patients were randomized into the EMBOLDEN studies, which included a 52-week treatment continuation phase following an initial treatment period of 8 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.
SEROQUEL XR is currently approved in 16 countries including US, Canada and several European countries, for the acute and maintenance treatment of schizophrenia in adults. National licenses are being progressed in a further 11 European countries following the successful completion of the EU Mutual Recognition Procedure. Launched in 1997, SEROQUEL is approved in 88 countries for the treatment of schizophrenia, in 79 countries for the treatment of bipolar mania, and in 11 countries including the USA for the treatment of bipolar depression. SEROQUEL XR was launched for the treatment of schizophrenia in the US in 2007, and its clinical development program and planned regulatory filings extend through bipolar disorder to major depressive disorder (MDD) and generalized anxiety disorder (GAD).
AstraZeneca is a major international healthcare business engaged in research, development, manufacturing and marketing of prescription pharmaceuticals and supplier for healthcare services. AstraZeneca is one of the world’s leading pharmaceutical companies with healthcare sales of US $29.55 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection product sales. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.
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