AstraZeneca's new statin, Crestor, receives approval in Canada
AstraZeneca's new statin, Crestor, receives approval in Canada
LONDON, U.K., Feb. 19, 2003 -- AstraZeneca announced that it has received approval for Crestor (rosuvastatin) 10-40 mg from the Therapeutic Products Directorate of Health Canada, for the management of primary hypercholesterolaemia, mixed dyslipidaemia, and familial hypercholesterolaemia, in Canada. The company will launch in Canada, immediately.
Dr. Hamish Cameron, Vice President and Head of Cardiovascular Therapy Area at AstraZeneca, said, "Canada is the first major commercial market to receive approval for Crestor, and as well as being another important milestone, it is also great news for the 10 million people with dyslipidaemia in Canada. With the efficacy we've seen in clinical studies, Crestor could make a real difference to these patients' lives."
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 per cent to 63 per cent across the dose range, and compared to the same doses of atorvastatin, Crestor provided a significant 8.4 per cent greater reduction in LDL-C.
Crestor 10mg gets significantly more patients to their European LDL-C goal than atorvastatin 10mg (82 per cent v 51 per cent respectively), simvastatin 20mg (80 per cent v 48 per cent) and pravastatin 20mg (80 per cent v 16 per cent). 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 was approved in the Netherlands last year and subsequently entered the European Mutual Recognition Procedure, which will lead to further approvals in 16 other countries in Europe -- beginning in the first half of 2003. Crestor has also recently been approved in Singapore and is awaiting approval in the U.S., Japan, and in other markets.
Source: AstraZeneca
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