AstraZeneca today announced that the once-daily formulation SEROQUEL XR™ (quetiapine fumarate extended release tablets) and SEROQUEL® (quetiapine fumarate) have been approved via the Mutual Recognition Procedure for new indications in bipolar disorder. SEROQUEL XR and SEROQUEL have been approved for treatment of major depressive episodes in bipolar disorder. Additionally, SEROQUEL XR has been approved for treatment of moderate to severe manic episodes in bipolar disorder.
This follows the October 2008 approval of SEROQUEL XR in similar indications by the U.S. Food and Drug Administration (FDA). As a result of these new indications for adult patients, SEROQUEL (both formulations) is currently the only atypical antipsychotic approved to treat the spectrum of mood episodes associated with bipolar disorder and the only licensed treatment for bipolar depression in the EU. The mechanism of action of SEROQUEL, which involves both antipsychotic and antidepressant activities, may help explain its unique efficacy across the spectrum of mood episodes associated with bipolar disorder.
AstraZeneca will move forward with obtaining local approvals with the 17 Member States that take part in the Mutual Recognition Procedure.
Bipolar disorder is a common and serious mental illness that causes dramatic and severe mood swings. Bipolar I disorder is the classic form of the disease, characterised by recurrent episodes of mania and depression. Bipolar II disorder involves one or more periods of major depression with at least one episode of mild to moderate mania (hypomania), but never full mania. It is estimated that the worldwide prevalence of bipolar disorder is 3-5%.1 Up to half of all individuals with bipolar disorder have at least one suicide attempt in their lifetime, and approximately 10-15% complete suicide.1,2 Currently, there is no licensed treatment for bipolar depression in the EU, making this approval a significant step forward for clinicians and patients.
Results from the randomised, double-blind trials submitted to support the two new indications show that SEROQUEL XR significantly reduced depressive and manic symptoms as early as the first week of treatment (day 4 for mania), and that significant improvements were maintained for the duration of the studies. Approval for the bipolar depression indication was based on an 8-week study in which SEROQUEL XR significantly improved scores on the Montgomery-Åsberg Depression Rating Scale (MADRS) compared with placebo at week 1 through week 8 (both P<0.001).3 The efficacy of SEROQUEL in bipolar depression has been demonstrated consistently in randomised clinical studies with both bipolar I disorder and bipolar II disorder patients, including the BOLDER4,5 and EMBOLDEN6,7 studies which together enrolled more than 2500 patients. All four studies reported significant improvements in symptoms of depression for patients with bipolar disorder treated with SEROQUEL. Approval for the bipolar mania indication was supported by a 3-week trial with SEROQUEL XR, which found significant improvements in Young Mania Rating Scale (YMRS) scores at day 4 through study end for SEROQUEL XR recipients compared with placebo (both P<0.001).8
Treatment with SEROQUEL and SEROQUEL XR was shown to be generally well tolerated in all studies and adverse events were consistent with the known safety profile of quetiapine. The most common adverse events associated with SEROQUEL XR in both studies were dry mouth, somnolence and sedation. The most common adverse events associated with SEROQUEL were dry mouth, sedation, somnolence, dizziness and constipation in the BOLDER studies, somnolence, dry mouth and dizziness in the acute phase of EMBOLDEN I, and dry mouth, somnolence and sedation in the acute phase of EMBOLDEN II.
About SEROQUEL XR and SEROQUEL
SEROQUEL XR has been approved in 43 countries for schizophrenia (including all 17 countries in the Mutual Recognition Procedure), 12 countries for bipolar mania, in 7 countries for bipolar depression, in 3 markets for bipolar maintenance, in 1 market for major depressive disorder (MDD), and in 1 market for generalised anxiety disorder (GAD). SEROQUEL XR is presented as tablets delivering a dose of 50 mg, 150 mg, 200 mg, 300 mg, or 400 mg of quetiapine free-base.
A filing for SEROQUEL XR seeking approval for the treatment of MDD was made in the US in February this year with the EU filing in June. In October 2008, SEROQUEL XR became the first atypical antipsychotic to be filed with the EMEA in Europe seeking approval for the treatment of GAD. A similar filing was made to the FDA in May 2008. These applications remain under review by the regulatory authorities.
Launched in 1997, it is estimated that SEROQUEL has been prescribed to more than 22 million patients worldwide*. It is approved in 92 countries for the treatment of schizophrenia, in 88 countries for the treatment of bipolar mania, and in 30 countries including the US for the treatment of bipolar depression.
*Estimates based on IMS APLD and Prescription data.
About AstraZeneca
AstraZeneca is a major international healthcare business engaged in research, development, manufacturing and marketing of prescription pharmaceuticals and supplier for healthcare services. AstraZeneca is one of the world’s leading pharmaceutical companies with healthcare sales of US $29.55 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection product sales. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.
http://www.astrazeneca.com
References
1. Shastry BS. Bipolar disorder: an update. Neurochem Int 2005;46:273-9.
2. Jamison KR. Suicide and bipolar disorder. J Clin Psychiatry 2000;61 Suppl 9:47-51.
3. Suppes T, et al. Effectiveness of the new extended release formulation of quetiapine as monotherapy for the treatment of acute bipolar depression (trial D144CC00002). Presented at the Eighth International Review of Bipolar Disorder Conference, Copenhagen, Denmark, 14-16 April, 2008.
4. Calabrese JR, et al. A randomized, double-blind, placebo-controlled trial of quetiapine in the treatment of bipolar I or II depression. Am J Psychiatry 2005;162:1351-60.
5. Thase ME, et al. Efficacy of quetiapine monotherapy in bipolar I and II depression: a double-blind, placebo-controlled study (the BOLDER II study). J Clin Psychopharmacol 2006;26:600-9.
6. Young AH, et al. Placebo-controlled study with acute and continuation phase of quetiapine in adults with bipolar depression (EMBOLDEN I). Presented at the European College of Neuropsychopharmacology Congress, Barcelona, Spain, 30 August-3 September, 2008.
7. McElroy S, et al. Placebo-controlled study with acute and continuation phase of quetiapine in adults with bipolar depression (EMBOLDEN II). Presented at the European College of Neuropsychopharmacology Congress, Barcelona, Spain, 30 August-3 September, 2008.
8. Cutler A, et al. Effectiveness of extended release formulation of quetiapine as monotherapy for the treatment of acute bipolar mania (trial D144CC00004). Presented at the Eighth International Review of Bipolar Disorder Conference, Copenhagen, Denmark, 14-16 April, 2008.
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