<div><p>Federal regulators have granted AstraZeneca approval to market its cholesterol pill Crestor as a preventive measure against heart attack and stroke in patients with healthy cholesterol levels.</p><p>The Food and Drug Administration decision will allow the company to promote Crestor to millions of U.S. patients who traditionally have not been candidates for cholesterol-lowering drugs.</p><p>The agency posted a briefing on the approval to its Web site late Monday.</p><p>London-based AstraZeneca studied the new use in a much-heralded 2008 study, showing Crestor reduced heart attack, stroke and other problems by 44 percent in patients with normal cholesterol and slight heart disease risks.</p><p>All the patients had elevated levels of the so-called C-reactive protein, a key indicator of inflammation that can lead to clogged arteries, causing heart attack or stroke.</p><p>Scientists are still unsure whether the positive results were due to lower cholesterol or C-reactive protein, since Crestor reduces both.</p><p>Under the new language, Crestor is approved for men 50 and older, and women 60 and older who have elevated C-reactive protein. Patients must also have at least one risk factor for heart trouble, such as high blood pressure or a smoking habit.</p><p>The FDA has previously estimated more than 6 million people in the U.S. could be eligible for Crestor under the expanded labeling.</p><p>However, in a release posted to its Web site Monday, the FDA suggested that doctors must identify the patients who are the best candidates for Crestor.</p><p>"Health care professionals must interpret the results of the Jupiter trial with caution," states the FDA, referring to the study which provided the basis for approval.</p><p>The FDA warns that Crestor patients in the Jupiter study were more likely to develop diabetes than those taking a placebo. However, there is evidence that diabetes is a side effect of all so-called statin drugs, which include Merck's Zocor and Pfizer's Lipitor.</p><p>"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," said AstraZeneca's Chief Medical Officer, Howard Hutchinson.</p><p>Crestor is already a blockbuster-selling drug for AstraZeneca, with revenue rising 29 percent to $4.5 billion last year. The drug was AstraZeneca's third best-selling drug product behind the heartburn drug Nexium and schizophrenia treatment Seroquel.</p><p>Since the publication of the last year's study, Crestor has increasingly been taking share away from competitors.</p><p>Shares of the Anglo-Swedish drugmaker rose 28 cents to $34.40 in afterhours trading.</p><img src="http://admatch-syndication.mochila.com/images/ad.gif?aid=68714902&bid=informcom" /></div><div id="copyright"><div>

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