29th Feb 2008 07:01
AstraZeneca PLC29 February 2008 AstraZeneca Submits sNDA for Seroquel XR(TM) for the Treatment of Major Depressive Disorder AstraZeneca today announced submission of a supplemental New Drug Application(sNDA) to the U.S. Food and Drug Administration (FDA) for once-daily SEROQUEL XR(TM) (quetiapine fumarate) Extended-Release Tablets to seek approval for the treatment of major depressive disorder (MDD) as monotherapy, adjunct therapy, and maintenance therapy in adult patients. MDD affects 15 million American adults - between 5 and 8 percent of thepopulation each year - and today it is often treated with generic or brandedantidepressants. Studies have shown that at least one-third of patients with MDDtreated with antidepressants fail to achieve a satisfactory response. TheAmerican Psychiatric Association Practice Guidelines recommend switching toanother class when two medications from the same class have proven ineffective.AstraZeneca has investigated the use of SEROQUEL XR, an atypical antipsychotic,in the treatment of MDD, aiming to develop another potential treatment option,including treatment for patients who have failed or had an inadequate responseto another antidepressant therapy. The MDD submission is based on seven Phase III, placebo-controlled studies thatassessed the efficacy and safety of once-daily treatment with SEROQUEL XR inpatients diagnosed with MDD. Studies 1, 2, 3, and 4 were acute monotherapystudies involving 2,116 patients; Studies 6 and 7 were acute adjunct therapystudies (with ongoing antidepressant therapy) involving 939 patients who had aninadequate response to an antidepressant therapy; and Study 5 was a longer-term(up to 78 weeks) monotherapy maintenance study involving 1,854 patients. Theacute studies included in this submission used the Montgomery-Asberg DepressionRating Scale (MADRS) as the primary assessment of depression symptoms. In thelonger term study (Study 5), the primary assessment was time to a depressedevent using criteria including MADRS. Doses of 50 mg, 150 mg and 300 mg ofSEROQUEL XR were studied in the MDD programme. Across the whole programme,patients entering treatment in these seven clinical studies were drawn from 27countries - three-quarters of the patients were in North America - a further 10percent were in Western Europe, 6 percent in Eastern Europe and the remainderwere in Asia, South America, South Africa and Australia. SEROQUEL XR(TM) is approved in the US and 18 further countries for the treatmentof schizophrenia in adult patients and for maintenance treatment ofschizophrenia in adult patients. It was launched in the US in 2007 and lastmonth AstraZeneca announced the submission of two separate sNDAs to the FDA forSEROQUEL XR seeking approval for the treatment of manic episodes associated withbipolar disorder and the treatment of depressive episodes associated withbipolar disorder - these remain under review by the FDA. In addition to thesubmission for MDD, the clinical development programme and planned regulatoryfilings for Seroquel XR extend to generalised anxiety disorder (GAD). Launched in 1997, SEROQUEL(R) (quetiapine fumarate) is approved in 88 countriesfor the treatment of schizophrenia, in 79 countries for the treatment of bipolarmania, and in 11 countries including the USA for the treatment of bipolardepression. Global sales of Seroquel for 2007 passed the $4 billion mark for thefirst time, up 15 per cent on the previous year. About Major Depressive Disorder Major depressive disorder is a serious medical illness affecting 15 millionAmerican adults, or approximately 5 to 8 percent of the adult population in agiven year. Depression occurs twice as frequently in women as in men. Unlikenormal emotional experiences of sadness, loss, or passing mood states, majordepressive disorder is persistent and can significantly interfere with anindividual's thoughts, behaviour, mood, activity, and physical health. Among allmedical illnesses, major depressive disorder is the leading cause of disabilityin the U.S. and many other developed countries. Symptoms of major depressive disorder characteristically represent a significantchange from how a person functioned before the illness. The symptoms ofdepression include: persistently sad or irritable mood; pronounced changes insleep, appetite, and energy; difficulty thinking, concentrating, andremembering; physical slowing or agitation; lack of interest in or pleasure fromactivities that were once enjoyed; feelings of guilt, worthlessness,hopelessness, and emptiness; recurrent thoughts of death or suicide; andpersistent physical symptoms for two or more weeks that do not respond totreatment, such as headaches, digestive disorders, and chronic pain.Symptomatically, a major depressive episode in MDD is similar to a depressiveepisode of bipolar disorder with the major distinguishing feature between thedisorders being the absence of manic or hypomanic symptoms in MDD. It has beenreported that 69 per cent of patients with bipolar disorder were misdiagnosed,with the most frequent misdiagnosis being MDD. About AstraZeneca AstraZeneca is a major international healthcare business engaged in theresearch, development, manufacture and marketing of prescription pharmaceuticalsand the supply of healthcare services. It is one of the world's leadingpharmaceutical companies with healthcare sales of $29.55 billion and leadingpositions in sales of gastrointestinal, cardiovascular, neuroscience,respiratory, oncology and infection products. AstraZeneca is listed in the DowJones Sustainability Index (Global) as well as the FTSE4Good Index. For more information about AstraZeneca, please visit: www.astrazeneca.com 29 February 2008 Media Enquiries: James Read, + 1 302 885 9944 (Wilmington, US) Media Enquiries: Steve Brown, +44 207 304 5033 (24 hours)Chris Sampson, +44 20 7304 5130 (24 hours)Neil McCrae, +44 207 304 5045 (24 hours) Investor Enquiries: Jonathan Hunt, +44 207 304 5087Ed Seage, +1 302 886 4065Karl Hard, +44 207 304 5322Jorgen Winroth, +1 212 579 0506Mina Blair, +44 20 7304 5084Peter Vozzo, (MedImmune) +1 301 398 4358 - Ends - This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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