Seroquel

AstraZeneca PLC 03 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 new indication for SEROQUEL(R) (quetiapine fumarate) for the treatment of patients with depressive episodes associated with bipolar disorder. SEROQUEL is currently approved for the treatment of acute manic episodes associated with bipolar I disorder and the treatment of schizophrenia. This sNDA submission is an important milestone in the history of SEROQUEL. If SEROQUEL receives approval from the FDA to treat bipolar depression, it would be the only single agent indicated to treat both the depressive and manic episodes associated with bipolar disorder. The sNDA submission is based on results from the clinical trial programme known as BOLDER (BipOLar DEpRession), which comprises two studies: BOLDER I and BOLDER II. Both studies were double-blind, placebo-controlled trials of outpatients (N =1,045) with bipolar I or II disorder. Patients were randomised to receive eight weeks' treatment with fixed doses of SEROQUEL (300 mg or 600 mg) or placebo administered once daily. In both studies, patients receiving SEROQUEL, as compared to those receiving placebo, showed a statistically significant decrease in depression scores at week one, and scores continued to decrease throughout the eight-week study. More than half of the SEROQUEL treated patients in each trial met the criteria for remission. Additionally, SEROQUEL was shown to have similar safety profiles in both BOLDER I and II. The most common adverse effects reported in these trials included dry mouth, 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 bipolar disorder are symptomatic almost half of their lives, and approximately two-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. Up to 50 per cent of patients with bipolar depression attempt suicide, and approximately 10 to 15 per cent commit suicide. Furthermore, bipolar disorder is often misdiagnosed, and patients may suffer up to 10 years before a correct diagnosis is made. SEROQUEL(R) (quetiapine fumarate) is the number one prescribed atypical antipsychotic in the United States and has a well-established safety and efficacy profile. In 2004, sales for SEROQUEL reached $2 billion. SEROQUEL has had 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 without depression. Bipolar II disorder consists of recurring episodes of depression and hypomania, a milder form of mania. In the long term, patients with bipolar I disorder spend three times longer in the depressed state than in mania. Patients with bipolar II disorder have traditionally been difficult to treat as they spend almost 40 times longer in the depressed state than in mania. Without appropriate treatment, patients usually suffer for a lifetime with periods of wellness and functioning punctuated by severe episodes of illness. Both men and women are equally at risk for this illness, which most often emerges in adolescence or young adulthood and recurs throughout life. ABOUT ASTRAZENECA AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of over $21.4 billion and leading positions in sales of gastrointestinal, cardiovascular, respiratory, oncology and neuroscience products. AstraZeneca is listed in the Dow Jones Sustainability 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 depressive symptoms including mood and sadness, tension, sleep, appetite, energy, concentration, and suicidal ideation. The MADRS score decreases as depressive symptoms improve. Remission was defined as a MADRS score of

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