AstraZeneca plc. (AZN) announced that the US Food and Drug Administration has approved Crestor, or rosuvastatin calcium to reduce the risk of stroke, myocardial infarction or heart attack and arterial revascularization procedures in individuals without clinically evident coronary heart disease but with an increased risk of cardiovascular disease or CVD based on age (men greater than or equal to 50 and women greater than or equal to 60), high-sensitivity C-reactive protein or hsCRP greater than or equal to 2 mg/L, and the presence of at least one additional CVD risk factor, such as hypertension, low HDL-C, smoking, or a family history of premature coronary heart disease.
The company said that the FDA approval was based on data from the landmark JUPITER or 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% (p<0.001), stroke="" by="" 48%="" (p="0.002)," and="" arterial="" revascularization="" by="" 46%=""><0.001) vs.="" placebo.="">
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