Federal health advisers say expanded use of AstraZeneca’s cholesterol pill Crestor can patients with healthy cholesterol levels by preventing heart attack, stroke and death.
A Food and Drug Administration panel 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 seller.
The FDA is not required to follow the group’s advice, though it usually does.
benefit A positive FDA ruling would give Crestor the broadest indication of any cholesterol drug in the U.S.
FDA’s panelist’s said the drug’s lifesaving potential outweighed side effects, including diabetes risk.
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