EU gives new Crestor indication the green light

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The European Union has granted approval to AstraZeneca's rosuvastatin (Crestor) for the prevention of major cardiovascular events (MACE) in high-risk patients who have a Framingham Risk Score greater than 20 percent.

According to AstraZeneca, the new indications are based on a substudy of the JUPITER (Justification for the Use of statins in Prevention: an Intervention Trial Evaluating Rosuvastatin) trial, which evaluated the use of a 20 mg dose of rosuvastatin compared to placebo and assessed its ability to reduce adverse events.

“This new indication is a significant milestone and means that rosuvastatin can now be prescribed to high-risk patients to prevent cardiovascular events including heart attacks and strokes,” said Michael Cressman, executive director of clinical research for Crestor.

The company said that during the JUPITER trial almost 9,000 patients were administered rosuvastatin and tolerated it well.

According to the company, Crestor is approved in over 100 countries and has already been administered to over 19 million patients.

The FDA approved Crestor as a measure of  preventative care in the U.S., February 9.