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ASTRAZENECA’S NEW STATIN, CRESTOR™, RECEIVES FIRST APPROVAL IN EUROPE - Other European markets should follow in 2003
- Reference code :
- wf456
- Published date :
-
07 November 2002
- Expired date :
-
25 March 2030
AstraZeneca announced today it has received the first approval for CRESTOR™ (rosuvastatin) 10-40 mg from the Medicines Evaluation Board (MEB) in the Netherlands for the management of primary hypercholesterolaemia and mixed dyslipidaemia.
Sir Tom McKillop, Chief Executive of AstraZeneca, said, "We are delighted to have received this first approval of CRESTOR, which represents another milestone for the company. CRESTOR is an outstanding product that will enable more patients across the world to reach their target LDL cholesterol levels, and aid in the global fight against coronary heart disease.”
The Netherlands MEB will act as the Reference Member State for the European Mutual Recognition Procedure leading to further approvals in 16 other countries in Europe--beginning in the first half of 2003. CRESTOR is also awaiting approval in the USA, Japan and in other markets.
The clinical development programme for CRESTOR now involves over 15,000 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 the currently prescribed statins. It has demonstrated reductions of 52% to 63% across the dose range, and compared to the same doses of atorvastatin, CRESTOR provided a significant 8.4% greater reduction in LDL-C. 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.
The excellent efficacy of CRESTOR, together with a safety profile, which the company believes is comparable to the marketed statins, will position CRESTOR as a highly effective competitor in the global statin market, estimated to be worth more than $18 billion and growing at a rate of about 20 per cent annually.
Dr Hamish Cameron, Vice President and Head of Cardiovascular Therapy Area at AstraZeneca, said, “Despite many medical advances, hypercholesterolaemia remains poorly controlled. Approximately half of the people on cholesterol lowering therapy are still not reaching their cholesterol targets and are at risk of heart attacks and strokes. With the efficacy we’ve seen in clinical studies, CRESTOR could make a real difference to these patients’ lives.”
A copy of the English version of the approved label for CRESTOR™ in The Netherlands (rosuvastatin) can be found at www.astrazeneca.com/redirector/index.asp?id=6
Details on the approval of CRESTOR™ (rosuvastatin) will be provided by Dr Hamish Cameron at 08.30 GMT today as a part of the company’s Annual Business Review. Details of this event can be found at www.astrazeneca.com/redirector/index.asp?id=5
AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of ethical (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 $16.4 billion and leading positions in sales of gastrointestinal, oncology, anaesthesia including pain management, cardiovascular, central nervous system (CNS) and respiratory products. AstraZeneca has more than 40 years experience in cardiovascular medicine and aims to increase lifespan and improve quality of life by reducing the risk, prevalence and impact of cardiovascular disease. AstraZeneca has a comprehensive cardiovascular portfolio including CRESTOR, ATACAND, ZESTRIL, TENORMIN, SELOKEN ZOK /TOPROL XL AND PLENDIL. This heritage is complemented by an innovative pipeline including the first oral direct thrombin inhibitor, EXANTA, and a novel treatment for type 2 diabetes / metabolic syndrome, GALIDA.
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Investor RelationsMina Blair-Robinson +44 (0)20 7304 5084 Jonathan Hunt +44 (0)20 7304 5087 |
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