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FDA Approves AstraZeneca's Seroquel(R) for Maintenance Treatment in Bipolar Disorder
Date:5/14/2008

WILMINGTON, Del., May 14 /PRNewswire-FirstCall/ -- AstraZeneca (NYSE: AZN) today announced that the U.S. Food and Drug Administration (FDA) has approved SEROQUEL(R) (quetiapine fumarate tablets) for the maintenance treatment of patients with bipolar I disorder, as adjunct therapy to lithium or divalproex. SEROQUEL is approved by the FDA for the treatment of schizophrenia, and is also the only single agent approved by the FDA for the treatment of both depressive episodes in bipolar disorder and acute manic episodes associated with bipolar I disorder. (1,2)

Considered one of the most severe forms of mental illness, bipolar disorder currently affects about 8 million adults in the U.S.(3-5) Bipolar I disorder is a lifelong psychiatric condition characterized by manic or mixed mood episodes, interspersed with major depressive episodes. (6) It is estimated that 0.4 percent to 1.6 percent of individuals will develop bipolar I disorder in their lifetime. (6)

"This new indication for SEROQUEL marks an important milestone in the treatment of bipolar I disorder because it provides patients with another option over the long-term. In fact, despite the number of currently available treatments, many patients with bipolar I disorder do not receive effective therapy and some 20 to 30 percent of patients continue to display residual mood symptoms of bipolar I disorder," said Mark Scott, Executive Director, Clinical Development, SEROQUEL. "The studies showed that SEROQUEL, with lithium or divalproex, can provide clinicians with a safe and effective long-term treatment option that reduced the risk of relapse of both manic and depressive mood events in bipolar I disorder."

The FDA approval was based on two multicenter, randomized, double-blind, placebo-controlled clinical trials that evaluated SEROQUEL when used as an adjunct therapy to lithium or divalproex in the maintenance treatment of adult patients with bipolar I disorder (n=703, n=623 respectively). (7
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SOURCE AstraZeneca
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