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GEN News Highlights : Dec 4, 2009

AstraZeneca’s Antidepressant Gets FDA Nod for Label Expansion

Seroquel XR has been sanctioned as an add-on for major depressive disorder.

AstraZeneca obtained FDA approval for once-daily Seroquel XR extended-release tablets as adjunctive treatment to antidepressants in adults with major depressive disorder (MDD). The sNDAs for Seroquel XR as acute monotherapy and maintenance monotherapy, however, have not yet been sanctioned, with the FDA asking for additional information.

FDA also recquires that AstraZeneca implement a Risk Evaluation and Mitigation Strategy (REMS) through a medication guide and periodic assessments that will include a survey of patients' understanding of the potential risks of the drug. The REMS applies to all approved indications.

FDA nod comes a day after AstraZeneca paid $200 million up front for global development rights Targacept’s MDD therapy. The drug is scheduled to enter Phase III trials next year, and Targacept could earn up to $1 billion if all milestones are met.

Seroquel XR was approved in the U.S. in 2007 for the treatment of schizophrenia in adult patients and in October 2008 for the acute treatment of the depressive episodes associated with bipolar disorder, the manic and mixed episodes associated with bipolar I disorder, and the maintenance treatment of bipolar I disorder as adjunctive therapy to lithium or divalproex.

“Today's FDA approval of Seroquel XR is based on a clinical-development program in MDD involving 939 patients randomized across two studies that assessed the efficacy and safety of once-daily treatment with Seroquel XR as adjunctive treatment to antidepressants,” says Lisa Schoenberg, vp specialty care.