AstraZeneca announced that the Committee for Medicinal Products for Human Use (CHMP), of the European Medicines Agency (EMA) concluded that the benefit-risk profile of once-daily Seroquel XR (quetiapine fumarate) extended-release tablets was positive as an add-on medication for major depressive episodes in major depressive disorder patients who have had sub-optimal response to treatment with other antidepressants.
The application was referred to the CHMP following a negative outcome for the application in 2009, during an assessment via the Mutual Recognition Procedure.
The EMA will now forward the opinion of the CHMP to the European Commission (EC) for their final decision, which will then be implemented in the individual Member States affected.
At 23 March 2010, Seroquel XR has been approved in 68 countries for schizophrenia, 56 countries for bipolar mania, in 47 countries for bipolar depression, in 27 markets for bipolar maintenance, in three markets for Generalised Anxiety Disorder (GAD), and in four markets for Major Depressive Disorder (MDD), with US receiving approval of Seroquel XR for the adjunctive treatment of MDD in December 2009.
AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialisation of prescription medicines.