AstraZeneca’s Seroquel Gets FDA Nod For Bipolar Depression
This article was originally published in The Pink Sheet Daily
Executive Summary
Seroquel is the first drug approved for both depressive and manic episodes associated with bipolar disorder, the firm says.
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AstraZeneca will continue detailing Seroquel (quetiapine) to primary care physicians and psychiatrists, but has no plans to launch a new ad campaign following an Oct. 20 sNDA approval for bipolar depression, the firm told "The Pink Sheet" DAILY Oct. 23. The approval makes Seroquel the first drug approved for depressive and manic episodes associated with bipolar disorder, according to AstraZeneca. FDA had previously approved Seroquel for treatment of acute manic episodes associated with bipolar disorder and for schizophrenia (1 (Also see "AstraZeneca Submits Seroquel sNDA For Bipolar Depression Indication" - Pink Sheet, 30 Dec, 2005.)). Recommended dosing for the new indication is 300 mg once-daily. Approval was based on results from two double-blind, placebo-controlled trials of 1,045 outpatients with bipolar I or II disorder. The most frequent adverse events seen during the eight-week trials were dry mouth, sedation, somnolence, dizziness, and constipation. AstraZeneca has a May 17, 2007 user fee date under a standard 10-month review for a once-daily, sustained-release version of Seroquel for schizophrenia (2 (Also see "Seroquel SR NDA Submitted For Schizophrenia" - Pink Sheet, 18 Jul, 2006.)). Seroquel SR would have patent protection until 2017; the immediate-release product is scheduled to go off patent in 2011. The firm announced last week that it had filed for marketing authorization for Seroquel SR in the European Union and Canada for schizophrenia. AstraZeneca confirmed to "The Pink Sheet" DAILY that it remains on track to submit a Seroquel SR sNDA for bipolar depression and generalized anxiety disorder in 2007 and for bipolar mania in 2008. - Daniel Fowler ([email protected]) |