FDA Advisory Committee Recommendation on Seroquel XR Supplemental New Drug Applications

Thursday, 9 April 2009 On 8 April 2009, the U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) conducted a review of the safety and efficacy of supplemental new drug applications (sNDA) for SEROQUEL XR (quetiapine fumarate) extended-release tablets proposed for the treatment of major depressive disorder (MDD) and generalised anxiety disorder (GAD). The Advisory Committee concluded: SEROQUEL XR was shown to be effective in MDD as both monotherapy and adjunctive therapy, and shown to be effective in GAD as monotherapy. SEROQUEL XR was shown to be acceptably safe as an adjunctive treatment for MDD. SEROQUEL XR was not shown to be acceptably safe as a monotherapy for broad treatment for MDD. The committee was undecided as to whether SEROQUEL XR was shown to be acceptably safe in certain instances as a monotherapy treatment for MDD. SEROQUEL XR was not shown to be acceptably safe as a monotherapy for the treatment of GAD. Howard Hutchinson, M.D., Chief Medical Officer of AstraZeneca, said: “We are pleased that the committee found SEROQUEL XR to be effective and acceptably safe for use as adjunctive therapy for the treatment of MDD. Although the committee recognised the effectiveness of SEROQUEL XR as monotherapy for MDD and GAD, they had concerns around the long-term safety profile in these new populations. We look forward to having further discussions with the FDA regarding both sNDAs.” The FDA frequently convenes advisory committee meetings to obtain independent expert guidance and recommendations on clinical matters. While the FDA is not required to follow this guidance, the agency usually takes the advice into consideration when rendering its final decisions on pending applications and other public health matters. SEROQUEL XR is not approved for the treatment of MDD and GAD. NOTES TO EDITORS: Questions to the Advistory Committee 1. Has Seroquel XR been shown to be effective as a treatment of: Yes No Abstain MDD as a adjunct therapy? 9 1 0 MDD as a monotherapy? 8 1 1 GAD as a monotherapy? 7 2 1 2. Has SEROQUEL XR been shown to be acceptably safe as an adjunctive treatment for MDD? Yes No Abstain 6 3 0 3. Has SEROQUEL XR been shown to be acceptably safe as a treatment for: Yes No Abstain MDD as a monotherapy? 0 9 0 GAD as a monotherapy? 0 9 0 4. Has SEROQUEL XR been shown to be acceptably safe in certain instances as a treatment: Yes No Abstain MDD as a monotherapy? 4 4 1 GAD as a monotherapy? 2 6 1 In due course the full vote will be available on the FDA web site. About SEROQUEL XR and SEROQUEL SEROQUEL XR, a once-daily, extended-release tablet formulation of SEROQUEL, was approved in the U.S. in 2007 for the acute and maintenance 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. About AstraZeneca AstraZeneca is a major international healthcare business engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US$ 31.6 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines. 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