FDA panel reviewer says benefits of AstraZeneca's Crestor outweigh risks

A US Food and Drug Administration medical reviewer has said the benefit of treating additional patients with Anglo-Swedish drug major AstraZeneca's cholesterol-lowerer Crestor (rosuvastatin) outweigh the drug's risks, according to press reports. However, the reviewer said additional study is needed to "further define this benefit-risk ratio."

The company reported that the FDA has posted briefing materials in advance of the December 15 meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) to discuss the supplemental New Drug Application (sNDA) filed by AstraZeneca..

In July, AstraZeneca announced that it had filed an sNDA with the FDA which seeks to incorporate outcomes data from the JUPITER study into the Crestor Prescribing Information. As noted in the FDA briefing materials, the sNDA filed by AstraZeneca includes a proposed draft indication based on the JUPITER study as follows:

'For the prevention of cardiovascular disease (CVD) in adult patients with an increased risk of cardiovascular disease based on the presence of cardiovascular disease risk markers such as an elevated hsCRP level, age, hypertension, low HDL-C, smoking or a family history of premature coronary heart disease, CRESTOR is indicated to:
' reduce the risk of total mortality
' reduce the risk of cardiovascular death
' reduce the risk of stroke
' reduce the risk of myocardial infarction
' reduce the risk of arterial revascularization
' reduce the risk of unstable angina'