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US FDA positive vote on Crestor

The US FDA Endocrinologic and Metabolic Drugs Advisory Committee has given a positive vote on the benefits of AstraZeneca's Crestor

Yesterday, the US Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 12 yes, four no, and one abstention that AstraZeneca has established sufficient benefit to offset the observed risks to support the use of 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; 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 information about the impact of Crestor on reducing the risk of cardiovascular events.

"AstraZeneca welcomes the Advisory Committee's positive vote," said Dr Howard Hutchinson, chief medical officer, AstraZeneca, speaking on December 15. "Today's discussions will help guide our ongoing dialogue 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.

16th December 2009

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