FDA panel backs new use for AstraZeneca's CrestorGAITHERSBURG, Md. — Federal health advisers said Tuesday that expanded use of AstraZeneca's cholesterol pill Crestor can benefit patients with healthy cholesterol levels by preventing heart attack, stroke and death.
A Food and Drug Administration panel of experts voted 12-4 with one abstention that Crestor's benefits outweigh its risks in patients with normal cholesterol and no history of heart disease, setting the stage for a dramatic expansion of a drug that is already a blockbuster.
The FDA is not required to follow the group's advice, though it usually does. A decision is expected in the first quarter of next year.
A positive ruling would allow AstraZeneca to market the drug to more than 6.5 million new patients who traditionally have not been candidates for cholesterol-lowering drugs.
The company based its request on a much-heralded study published last year, showing a 44 percent reduction in heart problems even among patients with normal cholesterol levels. All the patients had elevated levels of the so-called C-reactive protein, however, 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.
Panelists acknowledged the risks of Crestor, including a 27 percent higher rate of diabetes seen in patients taking the drug, compared with those taking a dummy pill. But the majority said the diabetes side effect is probably common to all statin drugs and that it is outweighed by Crestor's benefits.
"I do think the diabetes problem is real, but I'm comforted by the fact that the drug works even in that patient group, so it's very convincing," said Michael Proschan, a statistician with the National Institutes of Health.
The four panelists who voted against expanded use said they were uncomfortable recommending a drug with risks to patients who are healthy.
AstraZeneca officials said they would focus on marketing the drug to patients with health issues that put them at increased risk of heart problems, such as a smoking habit or family history of hypertension.
"Our goal is not to be treating very low-risk patients because in that setting the benefits might not be enough to outweigh the risks," said Howard Hutchinson, AstraZeneca's chief medical officer.
Crestor was AstraZeneca's third-best selling product last year with sales of $3.6 billion. Since the publication of the last year's study, Crestor has increasingly been taking share away from competitors, including Pfizer's Lipitor.
In the last quarter sales rose 30 percent to $1.15 billion compared with the prior year period.
Shares of AstraZeneca rose 32 cents Tuesday to close at $46.10.
Even as the British drugmaker moves toward expanding sales of Crestor, it is also fending off challenges to the franchise from would-be competitors.
Last week a judge in U.S. District Court of Delaware declined to dismiss a legal challenge to Crestor's patent from seven generic drug companies.
The companies — which include Mylan Pharmaceuticals, Apotex and Sandoz — are seeking to launch their own low-cost generic versions of Crestor. The case is slated to go to trial in February next year.
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