US FDA approves AstraZeneca's Crestor

AstraZeneca today said that the US Food and Drug Administration has approved rosuvastatin calcium under the brand Crestor.

It said in statement that the drug was indicated "to reduce the risk of stroke, myocardial infarction (heart attacks) and arterial revascularisation procedures in individuals without clinically evident coronary heart disease but with an increased risk of cardiovascular disease (CVD) based on age (men above 50 and women above 60), high-sensitivity C-reactive protein (hsCRP) ? 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."

It also said that 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 20mg on reducing major cardiovascular (CV) events in a previously unstudied population.

In Jupiter, Crestor significantly reduced the relative risk of heart attack by 54 per cent (p<0.001), stroke by 48 per cent (p=0.002), and arterial revascularization by 46 per cent (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 Crestoer therapy under this approved indication,'' the statement quoted 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.''

AstraZeneca also said that in addition to today's approval, Crestor is indicated in the US 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.