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| 29 August 2007 | 2007-08-29T00:00:00.0000000+01:00 |
| AstraZeneca’s Once-Daily SEROQUEL XR™ Extended-Release Tablets Approved in Netherlands For The Acute and Long Term Treatment Of Schizophrenia
AstraZeneca today announced the Netherlands regulatory authority MEB (Medicines Evaluation Board) has approved SEROQUEL XR™ (quetiapine fumarate) Extended-Release Tablets, a once-daily medicine for the treatment of schizophrenia in adult patients. With SEROQUEL XR™ patients can achieve a dose within the recommended range as early as the second day of treatment and the MEB approval also includes relapse prevention in the long-term treatment of schizophrenia. AstraZeneca will proceed with a Mutual Recognition Procedure, seeking similar approvals across Europe. SEROQUEL XR™ was approved for the treatment of schizophrenia in the US in May 2007. | SEROQUEL XR™ has been developed with the aim of improving dosing and titration options for patients and their doctors as they face the challenge of achieving successful treatment of schizophrenia. World Health Organisation (WHO) statistics indicate that schizophrenia affects about 24 million people worldwide. It subjects people to social isolation, poor quality of life and increased mortality. Schizophrenia is a severe mental disorder, characterised by profound disruptions in thinking, affecting language, perception, and the sense of self. It is estimated that SEROQUEL® (original formulation quetiapine) has been used to treat more than 19 million patients worldwide since its launch in 1997.
The MEB approval was based on clinical trials of SEROQUEL XR™ evaluating effectiveness and safety at doses of 400, 600, and 800 mg/day, in acute treatment, relapse prevention and also in a non-inferiority study of acute efficacy and safety when switching from the original formulation to SEROQUEL XR™.
Beyond schizophrenia, ongoing clinical studies of SEROQUEL XR™ cover bipolar disorder, major depressive disorder and generalised anxiety disorder. SEROQUEL® (original formulation quetiapine) is the number one prescribed atypical antipsychotic in the United States and global sales for SEROQUEL® reached $3.4 billion in 2006. It is licensed in 85 countries for the treatment of schizophrenia, in 73 countries for the treatment of mania associated with bipolar disorder, and in October 2006 it was approved in the US by the FDA for the treatment of bipolar depression.
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 $26.47 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.
SEROQUEL XR is a trademark of the AstraZeneca group of companies.
Media Enquiries:
Edel McCaffrey, Tel: +44 (0) 207 304 5034
Steve Brown, Tel: +44 (0) 207 304 5033
Investor Relations:
Mina Blair, Tel: +44 (0) 207 304 5084
Jonathan Hunt, Tel: +44 (0) 207 304 5087
Karl Hard, Tel: +44 (0) 207 304 5322
Jörgen Winroth, Tel: +1 (212) 579 0506
Ed Seage, Tel: +1 302 886 4065
Pete Vozzo, (MedImmune) Tel: +1 (301) 398 4358
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