Keywords: USA, FDA, AstraZeneca, Crestor, Cholesterol lowering

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

Article | 16 December 2009

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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.

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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.

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 filed by AstraZeneca in April this year to update the Crestor Prescribing Information with information about the impact of the drug on reducing the risk of cardiovascular events.

Howard Hutchinson, chief medical officer of the Anglo-Swedish drug major, said: “Today’s discussions will help guide our ongoing dialog with the FDA regarding our request for an indication that supports the use of Crestor for the prevention of cardiovascular disease in patients with an increased risk of experiencing cardiovascular events.”

The FDA Advisory Committee also discussed four non-voting items related to a range of other observations in JUPITER, including adverse events and whether the JUPITER trial identified an appropriate new target patient population. Among the concerns is a higher risk of developing diabetes