AstraZeneca has referred its application for Seroquel (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 application for MDD has been refused.
AstraZeneca believes that results from the clinical trial programme demonstrate that Seroquel has potential as a valuable treatment option for patients with MDD. The proposed indication in the submitted marketing application for Seroquel is for the treatment of recurrent depressive episodes in patients with MDD who are not appropriately managed on alternative antidepressant treatments.
AstraZeneca also announced that the Canadian regulators, Health Canada, have approved Seroquel for the treatment of adult patients with MDD.
Seroquel 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.