WASHINGTON (AP) - 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.
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.
The agency posted a briefing on the approval to its Web site late Monday.
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.
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.
Scientists are still unsure whether the positive results were due to lower cholesterol or C-reactive protein, since Crestor reduces both.
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.
The FDA has previously estimated more than 6 million people in the U.S. could be eligible for Crestor under the expanded labeling.
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.
"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.
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.
"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.
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.
Since the publication of the last year's study, Crestor has increasingly been taking share away from competitors.
Shares of the Anglo-Swedish drugmaker rose 28 cents to $34.40 in afterhours trading. |