Seroquel XR filed with FDA for MDD

Anglo-Swedish drug major AstraZeneca has submitted a supplemental New Drug Application to the US Food and Drug Administration seeking approval for the use of its drug Seroquel XR (quetiapine fumarate) in major depressive disorder. The UK-based firm said that it had requested clearance for the drug as a monotherapy, a maintenance therapy and as an adjunct to other medications.

Current data suggest that MDD affects around 15 million adults in the USA, with around one in three failing to achieve a satisfactory response to treatment. The MDD submission is based on data from seven Phase III placebo-controlled studies that examined Seroquel XR's safety and efficacy in 2,116 patients. The trials assessed the drug in all three of the treatment regimens for which approval is being sought, while one of the programs, which was conducted over a 78-week period, was designed to establish its long-term safety in this indication.

Since its launch in 1997, Seroquel has been variously approved as a treatment for schizophrenia, bipolar mania and bipolar depression in countries around the world. In February, AstraZeneca announced that it was seeking US approval for use of the extended-release formulation in the treatment of the manic episodes associated with bipolar depression and for depressive episodes associated with bipolar disorder under separate NDAs (Marketletter February 18).