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FDA panel backs increased use of AstraZeneca’s Crestor

World News | December 16, 2009


Kevin Grogan

AstraZeneca is pleased with the way a meeting with US regulatory advisors has gone as it could lead to a much broader indication for its blockbuster Crestor.

The US Food and Drug Administration’s Endocrinologic and Metabolic Drugs Advisory Committee has voted 12 yes, four no, and one abstention that the benefits benefits of Crestor (rosuvastatin) offset its risks in certain patients who have no prior history of cardiovascular or cerebrovascular events or coronary heart disease. The FDA panel reviewed data from the landmark 17,802 –patient Jupiter study which demonstrated that the drug cut deaths, heart attacks and strokes in middle-aged people with low-to-normal cholesterol but elevated high-sensitivity levels of C-reactive protein, an indicator of inflammation associated with heart disease.

The Jupiter data forms the basis of a supplemental New Drug Application filed by AstraZeneca in April to update the label on Crestor which could lead to millions of new patients being eligible for treatment with the statin. The company’s chief medical officer, Howard Hutchinson, said discussions with the panel “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 agency advisory committee also discussed four non-voting items, including adverse events and whether the Jupiyer trial identified an appropriate new target patient population. One panelist, Michael Criqui, a cardiologist at the University of California at San Diego, was quoted as saying that “there should be some caution in administering this to those who will clearly benefit”.

The panelists also looked at data which revealed a 27% higher rate of diabetes in patients who took Crestor, compared with those who received placebo, plus an increase in gastrointestinal-related deaths and patients on the drug being in a “confusional state. However, the broad conclusion of the panel is that these problems are common to all statins and further study is required.

If the FDA backs a change in label for Crestor or overall guidelines, sales of the AstraZeneca drug could soar. However some analysts believe that rise could be tempered by the introduction of generic copies of Pfizer’s rival drug Lipitor (atorvastatin) in 2011.

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