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AstraZeneca today announced that the company has submitted applications in the European Union (EU) for once-daily SEROQUEL XR(TM) (quetiapine fumarate) Extended-Release Tablets (quetiapine XR), seeking approval for the treatment of major depressive disorder (MDD) including maintenance therapy in adult patients using the Mutual Recognition Procedure (MRP)
London, UK | June 10, 2008 | AstraZeneca today announced that the company has submitted applications in the European Union (EU) for once-daily SEROQUEL XRTM (quetiapine fumarate) Extended-Release Tablets (quetiapine XR), seeking approval for the treatment of major depressive disorder (MDD) including maintenance therapy in adult patients using the Mutual Recognition Procedure (MRP). This follows a supplementary New Drug Application (sNDA) submission for SEROQUEL XR in MDD in the U.S. in February this year.
Each year, around 33 million people will suffer from MDD in Europe - between three and ten per cent of the population. Today, it is treated with generic or branded antidepressants, including SSRIs (selective serotonin reuptake inhibitors) and SNRIs (serotonin norepinephrine reuptake inhibitors). Studies have shown at least one-third of patients fail to achieve a satisfactory response with current antidepressant therapy. SEROQUEL XR is the first atypical antipsychotic medicine to be submitted in Europe for approval for the treatment of MDD. AstraZeneca has investigated its use in MDD as a potential new treatment option for patients who do not respond adequately to current treatments.
Data from eight randomised placebo-controlled studies of quetiapine XR at once-daily doses of 50, 150 and 300 mg in patients diagnosed with MDD support the submission announced today. These include four short-term monotherapy studies involving 2116 patients; two short-term adjunct therapy studies (with ongoing antidepressant therapy) involving 939 patients who had an inadequate response to prior antidepressant therapy; a longer-term monotherapy maintenance study involving 1,854 patients and up to 78 weeks of treatment; and a further short-term study involving 338 elderly patients. The short-term studies used the Montgomery-Åsberg Depression Rating Scale (MADRS) as the primary assessment of depression symptoms and the longer-term study assessed time-to-a-depressed-event using criteria including MADRS as the primary endpoint. The short-term studies demonstrated that quetiapine XR reduced depressive symptoms by week one whilst the long-term study demonstrated that efficacy was maintained. The safety and tolerability of quetiapine XR was consistent with the known safety profile of quetiapine.
AstraZeneca’s clinical development programme for quetiapine XR includes studies in Generalised Anxiety Disorder (GAD) and a European submission for that indication is planned for the second half of 2008.
About Major Depressive Disorder
Depression and depression-related problems such as suicide remain among the most pressing public health concerns in the development of European health policies. Studies have shown it is the biggest cause of disability (years of life lived with disability, YLD) with an economic cost of at least 1 per cent of Gross Domestic Product across countries through lost time and productivity at work, early death, hospital care and a range of other factors. In England alone, the estimated cost impact exceeds £ 9 billion - only a small fraction of this is spent on treatments.
Unlike the occasional sadness that is part of everyday life, or the grief associated with bereavement, a diagnosis of MDD is based on specific symptoms experienced for at least two weeks, during most of the time, and not normal for the individual concerned. It can significantly interfere with an individual’s thoughts, behaviour, mood, activity, and physical health.
Symptoms of major depressive disorder characteristically represent a significant change from how a person functioned before the illness. The symptoms of depression include: persistently sad or irritable mood; pronounced changes in sleep, appetite, and energy; difficulty thinking, concentrating, and remembering; physical slowing or agitation; lack of interest in or pleasure from activities that were once enjoyed; feelings of guilt, worthlessness, hopelessness, and emptiness; recurrent thoughts of death or suicide; and persistent physical symptoms for two or more weeks that do not respond to treatment, such as headaches, digestive disorders, and chronic pain.
About SEROQUEL and SEROQUEL XR
SEROQUEL XRTM is approved in the US and over 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. A SEROQUEL XR submission seeking approval for the treatment of MDD in the U.S. was announced in February, and a further submission in the U.S. seeking approval for the treatment of GAD was announced in May. SEROQUEL XR is not approved for these indications at this time and the 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 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 for Seroquel in 2007 were $4.027 billion – an increase of 15 per cent.
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.
SOURCE: AstraZeneca |
