Crestor rosuvastatin regulatory update

FDA approved an sNDA from AstraZeneca for Crestor rosuvastatin for the primary prevention of cardiovascular disease to reduce the risk of stroke, myocardial and arterial revascularization procedures in individuals without clinically evident coronary heart disease, but with an increased risk of cardiovascular disease based on age (men >=50 and women >=60), high-sensitivity C-reactive protein (hsCRP) >=2 mg/L, and the presence of at least 1 additional cardiovascular disease risk factor, such as hypertension, low HDL cholesterol (HDL-C), smoking or a family history of premature coronary heart disease. The company said FDA did not request additional follow-on trials or a safety registry to assess/monitor the risk of diabetes in patients taking the drug. In December, an FDA panel suggested that the agency request follow-on trials or a safety registry to assess/monitor the risk of diabetes in patients taking Crestor (see BioCentury, Dec. 15, 2009). ...