Singapore, Feb 09, 2010: AstraZeneca announced that the US Food and Drug Administration (FDA) has approved CRESTOR (rosuvastatin calcium) to reduce the risk of stroke, myocardial infarction (heart attack) and arterial revascularization procedures in individuals without clinically evident coronary heart disease but with an increased risk of cardiovascular disease (CVD).
The FDA approval was based on data from the landmark JUPITER (Justification for the Use of statins in Primary prevention: an Intervention Trial Evaluating Rosuvastatin) study which evaluated the impact of CRESTOR 20 mg on reducing major CVD events in a previously unstudied population. In JUPITER, CRESTOR significantly reduced the relative risk of heart attack by 54 percent, stroke by 48 percent and arterial revascularization by 46 percent vs. placebo.
"Not only is this approval a significant milestone for AstraZeneca, but it is also important for the patients who could now benefit from CRESTOR therapy under this approved indication," said Dr Howard Hutchinson, Chief Medical Officer, AstraZeneca. "This new indication adds to the significant body of evidence physicians use to evaluate CRESTOR as a treatment option."
In addition to the approval, CRESTOR is indicated as an adjunct to diet to reduce elevated Total-C, LDL-C, ApoB, non-HDL-C, and TG levels and to increase HDL-C in patients with primary hyperlipidemia and mixed dyslipidemia. CRESTOR is also indicated as an adjunct to diet to slow the progression of atherosclerosis in adult patients as part of a treatment strategy to lower Total-C and LDL-C to target levels.
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