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Home Industry News AstraZeneca reveals FDA acceptance of CRESTOR

AstraZeneca reveals FDA acceptance of CRESTOR

9th February 2010

AstraZeneca revealed this week that the Food and Drug Administration (FDA) has approved CRESTOR (rosuvastatin calcium) to reduce the risk of stroke, myocardial infarction and arterial revascularisation in individuals without coronary heart disease but with an increased risk of cardiovascular disease (CVD).

The approval was based on data from a study which evaluated the impact of CRESTOR 20 mg on reducing major CV events in a previously unstudied population.

During the trial, CRESTOR noticeably reduced the relative risk of heart attack by 54 per cent, stroke by 48 per cent and arterial revascularisation by 46 per cent, compared to placebo.

Howard Hutchinson, chief medical officer of AstraZeneca, said that the new indication will help physicians decide upon CRESTOR as a treatment option.

He furthered: “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.”

Earlier this week, AstraZeneca posted its financial results for the whole of 2009, revealing that its core operating profit for the full year increased by 23 per cent to $13,621 million (8.43 million pounds).

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