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Release issued 10th March 2003
AstraZeneca announced today that it has successfully completed the Mutual Recognition Procedure (MRP) in Europe for CRESTOR® (rosuvastatin) 10-40 mg for the management of primary hypercholesterolaemia and mixed dyslipidaemia. The Netherlands acted as the reference member state for the MR procedure, and CRESTOR has been launched in that market. National marketing authorisations in an additional 13 countries will be issued in the coming months.
Dr Gunnar Olsson, Head of the CV Therapy Area for AstraZeneca, said, "This is another significant milestone for CRESTOR and for AstraZeneca. We believe that the excellent efficacy, together with a safety profile comparable to the marketed statins, will position CRESTOR as a highly effective competitor in the global statin market."
Germany, Spain and Norway have been withdrawn from the MR process, and discussions will be held with their agencies to progress further regulatory options.
The global statin market is estimated to be worth approximately $19 billion and growing at a rate of around 15 per cent annually.
The clinical development programme for CRESTOR now involves over 16,000 patients and includes a number of head-to-head comparative studies. In multiple clinical studies, CRESTOR has been shown to be more effective in lowering LDL-cholesterol (LDL-C or 'bad cholesterol') than currently prescribed statins. CRESTOR 10mg gets significantly more patients to their European LDL-C goal than atorvastatin 10mg (82% v 51% respectively), simvastatin 20mg (80% v 48%) and pravastatin 20mg (80% v 16%). In addition to the dramatic reductions seen in LDL-C, CRESTOR produces a significant increase in HDL- C ('good cholesterol'), as well as reducing total cholesterol and triglycerides.
CRESTOR has been approved in Singapore and in Canada, where it was recently launched. It is awaiting approval in the USA, Japan and in other markets.
Cardiovascular disease is the leading cause of death worldwide, responsible for up to 17 million deaths per year. CRESTOR, a member of the statin class, is a once daily treatment for dyslipidaemia, a key risk factor in the development of cardiovascular disease, providing important benefits for both patients and health care professionals.
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 top five pharmaceutical companies in the world with healthcare sales of over $17.8 billion and leading positions in sales of gastrointestinal, oncology, anaesthesia (including pain management), cardiovascular, central nervous system (CNS) and respiratory products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global and European) as well as the FTSE4Good Index.
If you want to find out more about the company visit AstraZeneca profile.
(27th February 2003) ASTRAZENECA ISSUES 2002 ANNUAL REPORT
(6th August 2002) ASTRAZENECA UPDATE ON CRESTOR
(5th July 2002) ASTRAZENECA SECURES FIRST MARKET APPROVAL FOR IRESSA IN JAPAN
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