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 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.
