FDA Committee Looks Favorably on Giving Cholesterol Drug to Healthy People


December 16, 2009

December 16, 2009 – The FDA's Endocrinologic and Metabolic Drugs Advisory Committee yesterday agreed AstraZeneca established sufficient benefit with trial data showing prophylactic benefit of prescribing CRESTOR (rosuvastatin calcium) to healthy individuals to prevent heart disease.

The committee voted 12 yes, four no, and one abstention that the company showed the drug may help individuals meeting the following criteria: men greater than or equal to 50 years; women greater than or equal to 60 years; fasting LDL less than 130 mg/dL; hsCRP greater than or equal to 2 mg/L; triglycerides less than 500 mg/dL; and no prior history of cardiovascular or cerebrovascular events or coronary heart disease risk equivalent as defined by NCEP ATP-III guidelines.

The review, based on results of the JUPITER (Justification for the Use of statins in Prevention: an Intervention Trial Evaluating Rosuvastatin) study, is part of the FDA’s evaluation of the supplemental new drug application (sNDA) filed by AstraZeneca in April 2009 to update the CRESTOR prescribing information with data on the impact of CRESTOR in reducing the risk of cardiovascular events.

AstraZeneca said the committee’s positive vote will help guide the company’s ongoing dialogue with the FDA regarding its request for an indication that supports the use of CRESTOR for the prevention of cardiovascular disease.

The FDA frequently convenes advisory committee meetings to obtain independent expert guidance and opinions on clinical matters. While the FDA is not required to follow this guidance, the agency usually takes the advice into consideration when rendering its final decisions on pending applications and other public health matters.

Results from JUPITER were originally presented in November 2008 at the American Heart Association’s Annual Scientific Sessions and published by the New England Journal of Medicine. JUPITER was a long-term, randomized, double-blind, placebo-controlled, large-scale study of 17,802 patients. It was designed to determine if rosuvastatin 20 mg decreases the risk of myocardial infarction, stroke and other cardiovascular events in patients with LDL-C less than 130 mg/dL, but at increased cardiovascular risk as identified by age and elevated high-sensitivity C-reactive protein (hsCRP). The majority of patients had at least one other risk factor including hypertension, low HDL-C, family history of premature coronary heart disease or smoking. hsCRP is a recognized marker of inflammation, which is associated with an increased risk of atherosclerotic cardiovascular events.

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. The drug 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. CRESTOR is not approved to reduce cardiovascular morbidity and mortality.

For more information: www.astrazeneca-us.com