FDA Approves AstraZeneca’s Seroquel Maintenance Treatment in Bipolar Disorder
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AstraZeneca today announced that the U.S. Food and Drug Administration (FDA) has approved SEROQUEL® (quetiapine fumarate) for the maintenance treatment of patients with bipolar I disorder, as adjunct 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.
Considered one of the most severe forms of mental illness, bipolar disorder currently affects about 8 million adults in the US. Bipolar I disorder is a lifelong psychiatric condition characterised by manic or mixed mood episodes, interspersed with episodes of major depression. During their lifetime, between 0.4 per cent to 1.6 per cent of people will suffer from bipolar I disorder.
The FDA approval was based on two multicentre, randomised, 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). The rigourous study design included a 12 to 36 week stabilisation phase which was followed by up to two years of randomised double-blind treatment (mean duration of randomized quetiapine treatment was 189 days and 240 days respectively).
In both studies, patients with bipolar I disorder whose most recent episode was manic, depressed or mixed, were treated with either SEROQUEL (flexible dosing between 400mg and 800mg per day in divided doses) plus lithium-or-divalproex, or placebo plus lithium-or-divalproex. The primary endpoint, which was time to recurrence of a depressive, manic, or mixed mood event, compared with placebo, was significant for SEROQUEL compared with placebo in both studies. Pooled study results indicated that patients treated with SEROQUEL-plus-lithium-or-divalproex had a risk reduction of 70 per cent relative to those treated with placebo-plus-lithium-or-divalproex for time to recurrence of a mood event (HR: 0.30; 95% CI: 0.24, 0.37; p<0.001). This reduction in risk was significant for both recurrence of manic episodes (HR: 0.30; 95% CI: 0.22, 0.41; p<0.001), and recurrence of depressive episodes (HR: 0.30; 95% CI: 0.23, 0.40; p<0.001). The proportion of patients who relapsed when treated with SEROQUEL was 19.3% [125/646] versus 50.4% [343/680] of patients on placebo.
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About Bipolar Disorder
Approximately eight million American adults are affected by bipolar disorder, a serious psychiatric condition also known as manicdepressive illness. Bipolar disorder consists of recurring episodes of mania and depression. Bipolar I disorder is characterised by one or more manic or mixed episodes, often with episodes of major depression, whereas bipolar II disorder is distinguished by one or more major depressive episodes accompanied by at least one hypomanic episode. In the long term, patients with bipolar I disorder experience depressive symptoms, including prolonged periods of sadness, loss of energy, persistent lethargy, and recurring thoughts of death or suicide - three times longer than manic symptoms. Similarly, patients with bipolar II disorder spend almost 40-times longer in the depressed state than in hypomania. Bipolar disorder is often misdiagnosed as unipolar depression. This misdiagnosis can lead to unfocused treatment that may exacerbate the disease. In fact, many patients face up to ten years without appropriate treatment before a correct diagnosis is made. Up to 50 per cent of patients with bipolar disorder attempt suicide, and approximately 10 to 15 per cent complete suicide. Bipolar Disorder is typically managed through a treatment strategy with several phases - including acute and maintenance phases. In the acute phase, the aim is to improve the acute symptoms of the patient. The maintenance treatment phase aims to prevent the recurrence of the future episodes.
Adverse events in these trials, which were monitored during both the open-label stabilization phase and the randomized controlled-phase, were generally consistent with those reported in short term, placebo-controlled trials for SEROQUEL. In the pooled data of the two clinical studies, a greater incidence of blood glucose increases to hyperglycemic levels (> 126mg/dL) was observed in patients randomized to SEROQUEL plus lithium-or-divalproex than in patients randomized to placebo plus lithium-or-divalproex. The SEROQUEL prescribing information was updated in July 2007 to reflect the increases in blood glucose levels observed in these trials.
About SEROQUEL and SEROQUEL XR
Launched in 1997, it is estimated that SEROQUEL has been prescribed to more than 22 million patients worldwide. It is approved in 88 countries for the treatment of schizophrenia, in 79 countries for the treatment of bipolar mania, and in 11 countries including the US for the treatment of bipolar depression. Global sales of Seroquel in 2007 were $4,027 million - an increase of 15 per cent.
Beside today's announcement of the approval of SEROQUEL by the FDA in the US for the maintenance treatment of patients with bipolar I disorder, as adjunct to lithium or divalproex, a further submission was recently made seeking a similar approval in Europe, in line with previously announced clinical development plans. The European bipolar maintenance submission includes data from a study of SEROQUEL as monotherapy in the maintenance treatment of patients with bipolar I disorder.
SEROQUEL XRTM is approved in the US and 25 further countries for the treatment of schizophrenia in adult patients and for maintenance treatment of schizophrenia in adult patients. It was launched in the US in 2007 and earlier this year AstraZeneca announced the submission of regulatory applications in both the US and European Union for SEROQUEL XR in the treatment of manic episodes associated with bipolar disorder, and the treatment of depressive episodes associated with bipolar disorder. An sNDA for SEROQUEL XR seeking approval for the treatment of Major Depressive Disorder in the US was also announced in February. SEROQUEL XR is not approved for these indications at this time and the applications remain under review by the regulatory authorities.
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.
AstraZeneca (LSE/STO/Nasdaq: AZN) är ett globalt, innovationsdrivet bioläkemedelsföretag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel för sjukdomar inom terapiområdena Onkologi, Sällsynta sjukdomar och Bioläkemedel, inklusive kardiovaskulära sjukdomar, njursjukdomar och metabola sjukdomar (CVRM) samt Andningsvägar och Immunologi. AstraZeneca är baserat i Cambridge i Storbritannien och bedriver verksamhet i över 100 länder. Dess innovativa läkemedel används av miljontals patienter över hela världen.