Astra's Seroquel refused as MDD treatment

29th May 2009 07:18

Drug major AstraZeneca's application for Seroquel XR extended release tablets to treat recurrent depressive episodes in adult patients with major depressive disorder (MDD) has been refused.As a result, it has referred its application to the Committee for Medicinal Products for Human Use (CHMP - a scientific committee of the European Medicines Agency, EMEA). The company was notified of the decision by the Netherlands Health Authority, acting as the reference member state for the Mutual Recognition Process (MRP)."AstraZeneca believes that results from the clinical trial programme demonstrate that Seroquel XR has potential as a valuable treatment option for patients with MDD," read a short statement Friday."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." But Canadian regulators, Health Canada, have approved the schizophrenia drug for the treatment of adult patients with MDD, Astra said today.