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FDA approves preventative use of Crestor

AstraZeneca has announced the US Food and Drug Administration has approved its statin, Crestor, for the prevention of cardiovascular disease

AstraZeneca (AZ) has announced that the US Food and Drug Administration (FDA) has approved the use of its statin, Crestor (rosuvastatin calcium), for the prevention of cardiovascular disease (CVD).

Crestor will be targeted at a new market of potential patients with no previous problems with cholesterol, but with an increased risk of CVD due to high levels of C-reactive protein (CRP) – a sign of inflammation associated with heart disease - plus at least one other risk factor, including smoking or hypertension.

Patients should also be 50 or above if male, and 60 or above if female.

The approval was based on data from AZ's Jupiter (Justification for the Use of statins in Primary prevention: an Intervention Trial Evaluating Rosuvastatin) study involving nearly 18,000 people with no clinically evident cardiovascular disease. Males were also at least 50, and women at least 60.

The placebo controlled trial found Crestor significantly reduced the relative risk of heart attack by 54 per cent, stroke by 48 per cent, and arterial revascularisation by 46 per cent.

In a statement concerning the approval, Dr Howard Hutchinson, the chief medical officer of AZ, said: "Not only is this approval a significant milestone for AstraZeneca, but it is also important for the patients who could now benefit from Crestor therapy under this approved indication."

"This new indication adds to the significant body of evidence physicians use to evaluate Crestor as a treatment option," he added.

9th February 2010

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