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| 22 July 2004 | 2004-07-22T12:40:00.0000000+01:00 |
| DOUBLE BOOST FOR SEROQUEL™
Thursday 22nd July
FDA APPROVES 12-WEEK LABEL IN MANIA
AstraZeneca announced today that the U.S. Food and Drug Administration (FDA) has approved additional efficacy labelling information, based on 12-week data for SEROQUEL (quetiapine), a psychotropic medication indicated for the treatment of acute manic episodes associated with bipolar I disorder. SEROQUEL is the first medication in its class to include monotherapy safety and efficacy data for acute manic episodes associated with bipolar disorder extending beyond three weeks in its label. These latest data demonstrate that SEROQUEL treatment alone works early and continues to work through 12 weeks. | The data, part of the large scale effort to examine SEROQUEL's use in bipolar disorder, showed that after 12 weeks, approximately two-thirds of patients receiving SEROQUEL alone experienced significant improvement in manic symptoms and achieved remission. (Remission defined as a score of less than 12 on the Young Mania Rating Scale). For patients with bipolar disorder and their clinicians, it is important to know that SEROQUEL is not only effective in reducing symptoms of acute mania the first few weeks, but is also effective in the subsequent 'continuation phase', when patients can continue to have significant symptoms and are still at risk of relapsing.
The new label information is supported by data from two, 12-week, double-blind, randomised, placebo-controlled trials assessing the safety and efficacy of SEROQUEL monotherapy for the treatment of manic episodes in a large cohort of adults with bipolar I disorder. A total of 599 patients experiencing a manic episode were assigned to receive SEROQUEL (from 200 mg/day up to 800 mg/day), placebo, or an active control (lithium or haloperidol). The primary endpoint was change from baseline YMRS (Young Mania Rate Scales) total score at day 21 of treatment (week three); secondary endpoints included change from baseline YMRS total score at day 84 (week 12). The combined analysis of two 12-week, monotherapy, double-blind, placebo-controlled trials showed that:
- After 12 weeks, 66.8 percent of SEROQUEL-treated patients achieved a response (defined as greater than or equal to 50 percent decrease from baseline YMRS score) versus 40.0 percent of the placebo group (p<0.001).
- After 12 weeks, 65.4 percent of SEROQUEL-treated patients achieved remission (defined as YMRS less than or equal to 12), versus 35.9 percent with placebo (p<0.001).
- Improvement in manic symptoms based on change in YMRS score in patients treated with SEROQUEL was significantly greater than placebo-treated patients, as early as day four onwards (p=0.02).
Bipolar disorder is a serious mental illness that affects almost 4 percent of the adult population and is the sixth leading cause of disability in the world. More than half of those with bipolar disorder stop taking their medication at some point during their illness, subjecting themselves to a high risk of relapse and an increased risk of suicide. A medication's overall efficacy and tolerability profile is therefore vital to helping patients comply with their medication.
SEROQUEL was originally approved by the FDA in January 2004 as a monotherapy and adjunct therapy with lithium or divalproex, for the short-term treatment of acute manic episodes associated with bipolar I disorder. This approval was based on efficacy results following three weeks of treatment. These trials showed SEROQUEL to be well-tolerated and effective in the treatment of manic episodes - excited mental states seen in bipolar disorder that are characterized by impulsive behaviour, racing thoughts, pressured speech, and decreased need for sleep.
STUDY SUGGESTS POTENTIAL BENEFITS IN AGITATION ASSOCIATED WITH DEMENTIA
AstraZeneca today also announced important new data showing that SEROQUEL may be an effective option for the treatment of agitation associated with dementia, including Alzheimer's disease, in the elderly patient population. The results, presented at the 9th International Conference on Alzheimer's Disease and Related Disorders in Philadelphia, show that elderly patients with dementia who were treated with SEROQUEL, experienced improvement in symptoms of agitation. Additionally, patients treated with SEROQUEL showed no cerebrovascular adverse events (CVAEs), which have been associated with the use of some other atypical antipsychotics in this patient population.
The STAR trial, a 10-week, multicentred, double-blind, fixed-dose, 3-arm, placebo-controlled trial, randomised 333 institutionalised patients (mean age 83 years) to receive SEROQUEL 200mg/day, SEROQUEL 100mg/day or placebo. The key efficacy measures were the Positive and Negative Syndrome Scale-Excitement Component (PANSS-EC) and Clinicians' Global Impression of Change (CGI-C) scales. These efficacy measures were analysed in the Intent to Treat (ITT) and Per Protocol (PP) populations using the Last Observation Carried Forward (LOCF) and Observed Case (OC) methods. Trial results showed: - patients receiving SEROQUEL 200mg/day experienced significantly reduced symptoms of agitation compared to placebo as measured by PANSS-EC scores in three analyses (p<0.05), with a trend towards significance (p=0.065) in the fourth analysis (ITT, LOCF)
- the clinical relevance of the improvement in PANSS-EC is confirmed by the statistically significant improvement in CGI-C scores (p<0.02) in the SEROQUEL 200mg/day group compared with placebo in all four analyses
- no CVAEs were reported in any patients receiving SEROQUEL
- the incidence of postural hypotension was low; incidence of falls and hip fractures were similar among the treatment groups.
Additional results presented at the Conference, from two pooled, placebo-controlled, 10-week trials, also support the CVAE findings of the STAR trial. 684 patients (mean age 83 years) were randomised to receive SEROQUEL, haloperidol, or placebo. The analysis found that elderly patients receiving SEROQUEL were not at an increased risk of CVAEs, such as stroke or transient ischaemic attacks (TIAs), as demonstrated by the following results:
- one patient in the SEROQUEL group (0.3 percent), one patient in the haloperidol group (0.9%) and four patients in the placebo group (1.9 percent) experienced CVAEs.
Dementia is a term for various progressive brain disorders, the most common being Alzheimer's disease, vascular dementia and dementia with Lewy bodies, that result in a loss of brain function. Symptoms of dementia include memory loss, problems with reasoning, judgement and speech, and the inability to perform everyday tasks. Behavioural and psychological disturbance, including agitation, have been reported in up to 90 percent of patients with dementia, which can result in patients becoming distressed and aggressive, putting an immense strain on caregivers and affecting their ability to care for the individuals.
"Agitation is a significant issue for patients suffering from this condition and their caregivers. It is an aspect of dementia that is both difficult to manage and emotionally troubling for those who care for patients suffering from dementia," said Pierre Tariot, M.D., Professor of Psychiatry, Medicine and Neurology at the University of Rochester. "These new study results are helpful, informative, and justify further investigation of SEROQUEL for agitation in dementia patients."
SEROQUEL has received licences for the treatment of mania associated with bipolar disorder in 42 countries, including Europe and the US. SEROQUEL has been licensed for the treatment of schizophrenia since 1997 and is available in 81 countries. SEROQUEL is the fastest growing product among the three leading brands in the atypical antipsychotic market. Sales during 2003 reached $1.5 billion and the product currently ranks second in the US antipsychotic market for new and total prescription share, having recently overtaken olanzapine.
Media Enquiries:
Steve Brown, +44 207 304 5033
Edel McCaffrey, +44 207 304 5034
Investor Enquiries:
Jonathan Hunt, +44 207 304 5087
Mina Blair-Robinson, +44 207 304 5084
Notes to Editors:
- All product names appear in upper case. SEROQUEL is a trademark of the AstraZeneca group of companies.
- 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 $18.8 billion and leading positions in sales of gastrointestinal, oncology, cardiovascular, neuroscience and respiratory products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global and European) as well as the FTSE4Good Index.
- In Neuroscience, AstraZeneca is dedicated to providing medicines that have the potential to change patients' lives. The company already markets several products including SEROQUEL, one of the fastest growing global antipsychotics with proven efficacy and a very favourable side effect profile; and ZOMIG, a reliable migraine therapy and a leader within the triptan market. The Neuroscience pipeline includes leading approaches for the treatment of depression and anxiety, overactive bladder, dementia and stroke, pain control and anaesthesia.
SEROQUEL is a trademark of the AstraZeneca group of companies.
For more information, please visit www.astrazenecapressoffice.com
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