AstraZeneca today announced that the company has referred its application for SEROQUEL XR (quetiapine fumarate) Extended Release Tablets for the treatment of recurrent depressive episodes in adult patients with major depressive disorder (MDD) to the Committee for Medicinal Products for Human Use (CHMP; a scientific committee of the European Medicines Agency, EMEA). This follows notification to AstraZeneca by the Netherlands Health Authority (MEB), acting as the Reference Member State for the Mutual Recognition Process (MRP), that the SEROQUEL XR application for MDD has been refused.
AstraZeneca believes that results from the clinical trial programme demonstrate that SEROQUEL XR has potential as a valuable treatment option for patients with MDD. The proposed indication in the submitted marketing application for SEROQUEL XR is for the treatment of recurrent depressive episodes in patients with MDD who are not appropriately managed on alternative antidepressant treatments.
Also, AstraZeneca announced that the Canadian regulators, Health Canada, have approved SEROQUEL XR for the treatment of adult patients with MDD.
About CHMP
The CHMP arbitrates in cases where the product manufacturer believes that further assessment of the file is required in the event of a non-approval via the MRP. The assessments conducted are based on scientific criteria to determine whether or not a product meets the necessary quality, safety and efficacy requirements to provide a positive risk-benefit profile of that product once it reaches the marketplace.
The company submitted the application for SEROQUEL XR to the regulatory authority in the Netherlands as part of the Mutual Recognition Procedure in June 2008 seeking approval for the treatment of major depressive disorder (MDD) including maintenance therapy.
Both SEROQUEL and SEROQUEL XR are approved in Europe for the treatment of bipolar disorder and schizophrenia, and this decision by AstraZeneca does not change any current recommendations for the treatment of patients taking SEROQUEL or SEROQUEL XR for approved indications.
About SEROQUEL XR and SEROQUEL
SEROQUEL XR has been approved in 53 countries for schizophrenia, 19 countries for bipolar mania, in 20 countries for bipolar depression, in nine markets for bipolar maintenance, in one market for Generalised Anxiety Disorder (GAD), and in two markets for Major Depressive Disorder (MDD), with Canada receiving approval in May 2009.
Launched in 1997, SEROQUEL has been approved in 94 countries for schizophrenia, 92 countries for bipolar mania, in 41 countries for bipolar depression and in 6 countries for bipolar maintenance.
About AstraZeneca
AstraZeneca is a major international healthcare business engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US$ 31.6 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines. For more information about AstraZeneca, please visit: www.astrazeneca.com.