The FDA has approved a new indication for the cholesterol lowering medication Crestor (rosuvastatin, AstraZeneca) to be used preventatively in people with particular heart disease risk factors.
According to the agency, the statin will now be indicated for the primary prevention of cardiovascular disease to reduce the risk of stroke, heart attack and the risk of arterial revascularization procedures (including CABG, bypass grafting of a peripheral artery or carotid artery, angioplasty or stent placement) in individuals who have no clinically evident heart disease but are at an increased risk of heart disease due to the combined effect of the following risk factors:
- Age (more than 50 years in men; more than 60 years in women);
- An elevated high-sensitivity C-reactive protein level (more than 2 mg/L); and
- Presence of at least one additional cardiovascular risk factor (e.g., high blood pressure, low HDL-C, smoking or a family history of premature heart disease).
In December 2009, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted (12 yes, four no and one abstention) that AstraZeneca has established sufficient benefit to offset the observed risks to support the use of Crestor in more individuals for more conditions.
According to the London-based AstraZeneca, the decision, based on results of the JUPITER (Justification for the Use of statins in Prevention: an Intervention Trial Evaluating Rosuvastatin) trial, is part of the FDA's evaluation of the supplemental new drug application, which the company filed in April 2009 to update the Crestor prescribing information with information about the impact of Crestor on reducing the risk of cardiovascular events.