FDA Approves New Indication for CRESTOR
AstraZeneca today 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) based on age (men greater than or equal to 50 and women greater than or equal to 60), high-sensitivity C-reactive protein (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 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% (p<0.001), stroke by 48% (p=0.002), and arterial revascularization by 46% (p<0.001) 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 Howard Hutchinson, MD, Chief Medical Officer, AstraZeneca. "This new indication adds to the significant body of evidence physicians use to evaluate CRESTOR as a treatment option."