FDA approves new labelling for Seroquel in bio...( Alderley Park UK — 23 July 2004 ...),Health

Alderley Park, UK — 23 July, 2004 -- AstraZeneca announced today that the U.S. Food and Drug Administration (FDA) has approved additional efficacy labelling information based on 12-week data for SEROQUEL (quetiapine), a psychotropic medication indicated for the treatment of acute manic episodes associated with bipolar I disorder. The data 1, part of the large scale effort to examine SEROQUEL's use in bipolar disorder, showed that after 12 weeks, approximately two-thirds of patients receiving SEROQUEL alone experienced significant improvement in manic symptoms and achieved remission .

SEROQUEL is the first medication in its class to include monotherapy safety and efficacy data for acute manic episodes associated with bipolar disorder extending beyond three weeks in its label.

"For patients with bipolar disorder and their clinicians, it's important to know that Seroquel is not only effective in reducing symptoms of acute mania the first few weeks, but is also effective in the subsequent continuation phase, when patients can still have significant symptoms and are still at risk for relapsing," said Jamie Mullen, MD, Senior Director of Clinical Research, AstraZeneca. "These data demonstrate that SEROQUEL treatment alone works early and continues to work through 12 weeks. For patients coping with this illness, this is good news."

SEROQUEL was originally approved by the FDA in January 2004 as a monotherapy and adjunct therapy with lithium or divalproex, for the short-term treatment of acute manic episodes associated with bipolar I disorder. This approval was based on efficacy results following three weeks of treatment. These trials showed SEROQUEL to be well-tolerated and effective in the treatment of manic episodes — excited mental states seen in bipolar disorder that are characterized by impulsive behaviour, racing thoughts, pressured speech, and decreased need for sleep. ^{1, 2}.

SEROQUEL has received
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Contact: Rupert Doggett
rupert.doggett@shirehealthinternational.com
44-207-471-1512
Shire Health International
23-Jul-2004

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