Amarin fish oil pill gets mixed FDA assessment
A study of Amarin Corp.’s fish oil drug uncovered no new safety risks, though the benefit of expanding use to people with “very high” triglycerides needs to first be weighed against separate studies, U.S. regulators said.
Food and Drug Administration staff made the determination about the prescription-grade omega-3 fatty acid, called Vascepa, in a report posted today. A panel of FDA advisers is scheduled to meet Oct. 16 to discuss expanded approval for the drug to people with only “high” triglycerides, a fat in the blood, who also are using a cholesterol-lowering statin.
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