US FDA panel gives majority support for broader indication on AstraZeneca's Crestor

As was widely expected following informal comments from a reviewer a few days ago (The Pharma Letter December 14), the US Food and Drug Administration's Endocrinologic and Metabolic Drugs Advisory Committee has voted 12 yes, four no, and one abstention that AstraZeneca has established sufficient benefit to offset the observed risks to support the use of its blockbuster cholesterol-lowerer Crestor (rosuvastatin calcium) in individuals meeting the following criteria:

* Men ≥ 50 years, women ≥ 60 years;
' Fasting LDL < 130 mg/dl; hscrp ≥ 2.0 mg/l; triglycerides >< 500 mg/dl; and >
' No prior history of cardiovascular or cerebrovascular events or coronary heart disease (CHD) risk equivalent as defined by NCEP ATP-III guidelines.

Assuming the FDA confirms this recommendation with final approval, a decision expected in the first quarter of 2010, AstraZeneca could extend the use of its drug to more than 6.5 million new patients who are currently not candidates for cholesterol-lowering therapy.