23rd Oct 2006 07:01
AstraZeneca PLC23 October 2006 FDA Approves AstraZeneca's SEROQUEL(R) for Bipolar Depression Treatment AstraZeneca has announced that the U.S. Food and Drug Administration (FDA) hasapproved SEROQUEL(R) (quetiapine fumarate) for the treatment of patients withdepressive episodes associated with bipolar disorder. SEROQUEL already isapproved for the treatment of acute manic episodes associated with bipolar Idisorder and for the treatment of schizophrenia. SEROQUEL is now the first andonly single medication approved by the FDA to treat both depressive and manicepisodes associated with bipolar disorder. The FDA approval was based primarily on results from the clinical trialprogramme known as BOLDER (BipOLar DEpRession), which comprises the BOLDER I andBOLDER II studies. In these studies, patients taking SEROQUEL showed animprovement in depressive symptoms starting at week one compared to those takingplacebo, and this improvement continued throughout the eight-week study. Therecommended dose is 300 mg once-daily, to be achieved by day four of treatment. More than seven million American adults are affected by bipolar disorder, aserious psychiatric condition also known as manic depressive illness. Patientswith bipolar disorder are symptomatic almost half of their lives, andapproximately two-thirds of that time is spent in the depressed phase of theillness. For many people with bipolar disorder, the depressive symptoms aresignificantly more debilitating than the manic symptoms associated with theillness. "The new indication for SEROQUEL provides physicians and their patients with asingle medication to treat both the depressive and manic episodes associatedwith bipolar disorder," said John Patterson, Executive Director Development,AstraZeneca. "Treating acute bipolar disorder with a single medication may helppatients adhere to their medication regimen." Both studies in the BOLDER programme were double-blind, placebo-controlledtrials of outpatients (N=1,045) with bipolar I or II disorder. Patients wererandomized to receive eight weeks of treatment with fixed doses of SEROQUEL(R)(300 mg or 600 mg) or placebo administered once-daily. Efficacy in bipolardepression was demonstrated in the studies at both 300 mg a day and 600 mg aday. No additional benefit was seen in the 600 mg a day dose groups.Therefore, the recommended dose is 300 mg once-daily, to be achieved by day fourof treatment. SEROQUEL was generally well tolerated, with adverse event types similar to thoseseen in other clinical trials of SEROQUEL in bipolar mania and schizophrenia.The most frequent adverse events seen in the bipolar depression trials were drymouth, sedation, somnolence, dizziness and constipation. Because the depressive symptoms associated with bipolar disorder are also seenin major depressive disorder, a proper diagnosis can be difficult to achieve. Infact, studies show that as many as 69 percent of people with bipolar disorderwere misdiagnosed, with the most frequent misdiagnosis being major depressivedisorder. This misdiagnosis can lead to unfocused treatment that may exacerbatethe disease. Beyond schizophrenia, bipolar mania and bipolar depression, the ongoing clinicaldevelopment programme includes investigations of the use of SEROQUEL in bipolarmaintenance. Regulatory filings for the treatment of schizophrenia with asustained release formulation of quetiapine fumarate, SEROQUEL SR(TM), weresubmitted this year to regulatory authorities in the US, EU and other markets.Ongoing SEROQUEL SR(TM) clinical studies also cover major depressive disorderand generalized anxiety disorder. SEROQUEL is the number 1 prescribed atypicalantipsychotic in the United States. With a well-established safety and efficacyprofile, SEROQUEL has had more than 19 million patient exposures worldwide sinceits launch in 1997. In 2005, global sales for SEROQUEL reached $2.8 billion. 23 October 2006 Media Enquiries:Edel McCaffrey, Tel: +44 (0) 207 304 5034Steve Brown, Tel: +44 (0) 207 304 5033 Investor Relations:Mina Blair, Tel: +44 (0) 207 304 5084Jonathan Hunt, Tel: +44 (0) 207 304 5087Ed Seage, Tel: +1 302 886 4065Jorgen Winroth, Tel +1 (212) 579 0506 -Ends- This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
Astrazeneca