FDA Approves New Indication for AstraZeneca's Crestor

February 8, 2010—AstraZeneca Pharmaceuticals LP (Wilmington, DE) announced that the US Food and Drug Administration (FDA) has approved an expanded indication for Crestor (rosuvastatin calcium) to reduce the risk of stroke, myocardial infarction, 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 ≥ 50 and women ≥ 60), high-sensitivity C-reactive protein ≥ 2 mg/L, and the presence of at least one additional CVD risk factor, such as hypertension, HDL-C, smoking, or a family history of premature coronary heart disease. The FDA has posted postmarket drug safety information about Crestor and the new approval on its Web site, www.fda.gov.

According to the company, 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 that evaluated the impact of 20 mg of Crestor in reducing major CVD events in a previously unstudied population. In JUPITER, the drug significantly reduced the relative risk of heart attack by 54% (P < .001), stroke by 48% (P = .002), and arterial revascularization by 46% (P < .001) versus placebo. In November 2008, Paul M. Ridker, MD, et al published the JUPITER trial's findings in the New England Journal of Medicine (2008;359:2195–2207).

AstraZeneca stated that in addition to the latest 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. It 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.