3rd Jan 2006 07:06
AstraZeneca PLC03 January 2006 London Stock Exchange Announcement AstraZeneca Submits sNDA For Seroquel(R) For Bipolar Depression Treatment Filing Seeks Approval of SEROQUEL as a Monotherapy Treatment for Bipolar Depression AstraZeneca today announced submission of a supplemental New Drug Application(sNDA) to the US Food and Drug Administration (FDA) to seek approval for a newindication for SEROQUEL(R) (quetiapine fumarate) for the treatment of patientswith depressive episodes associated with bipolar disorder. SEROQUEL iscurrently approved for the treatment of acute manic episodes associated withbipolar I disorder and the treatment of schizophrenia. This sNDA submission is an important milestone in the history of SEROQUEL. IfSEROQUEL receives approval from the FDA to treat bipolar depression, it would bethe only single agent indicated to treat both the depressive and manic episodesassociated with bipolar disorder. The sNDA submission is based on results from the clinical trial programme knownas BOLDER (BipOLar DEpRession), which comprises two studies: BOLDER I and BOLDERII. Both studies were double-blind, placebo-controlled trials of outpatients (N=1,045) with bipolar I or II disorder. Patients were randomised to receive eightweeks' treatment with fixed doses of SEROQUEL (300 mg or 600 mg) or placeboadministered once daily. In both studies, patients receiving SEROQUEL, ascompared to those receiving placebo, showed a statistically significant decreasein depression scores at week one, and scores continued to decrease throughoutthe eight-week study. More than half of the SEROQUEL treated patients in eachtrial met the criteria for remission. Additionally, SEROQUEL was shown to have similar safety profiles in both BOLDERI and II. The most common adverse effects reported in these trials included drymouth, sedation, somnolence, dizziness, and constipation. Bipolar disorder, which affects more than seven million American adults,consists of recurring episodes of mania and depression. Patients with bipolardisorder are symptomatic almost half of their lives, and approximatelytwo-thirds of that time is spent in the depressed phase of the illness.Prolonged periods of sadness, unexplained loss of energy, persistent lethargy,and recurring thoughts of death or suicide characterise depressive episodes. Upto 50 per cent of patients with bipolar depression attempt suicide, andapproximately 10 to 15 per cent commit suicide. Furthermore, bipolar disorder isoften misdiagnosed, and patients may suffer up to 10 years before a correctdiagnosis is made. SEROQUEL(R) (quetiapine fumarate) is the number one prescribed atypicalantipsychotic in the United States and has a well-established safety andefficacy profile. In 2004, sales for SEROQUEL reached $2 billion. SEROQUEL hashad more than 13 million patient exposures worldwide since its launch in 1997. ABOUT BIPOLAR DISORDER Bipolar I disorder consists of recurring episodes of mania with or withoutdepression. Bipolar II disorder consists of recurring episodes of depressionand hypomania, a milder form of mania. In the long term, patients with bipolarI disorder spend three times longer in the depressed state than in mania.Patients with bipolar II disorder have traditionally been difficult to treat asthey spend almost 40 times longer in the depressed state than in mania. Withoutappropriate treatment, patients usually suffer for a lifetime with periods ofwellness and functioning punctuated by severe episodes of illness. Both men andwomen are equally at risk for this illness, which most often emerges inadolescence or young adulthood and recurs throughout life. 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 over $21.4 billion and leadingpositions in sales of gastrointestinal, cardiovascular, respiratory, oncologyand neuroscience products. AstraZeneca is listed in the Dow JonesSustainability Index (Global) as well as the FTSE4Good Index. Depression scores were measured by the Montgomery-Asberg Depression Rating Scale(MADRS). The MADRS scale measures the severity of a number of depressivesymptoms including mood and sadness, tension, sleep, appetite, energy,concentration, and suicidal ideation. The MADRS score decreases as depressivesymptoms improve. Remission was defined as a MADRS score ofRelated Shares:
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