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FDA Advisors Vote Against Expanded Use of Fish-Oil Pill, Vascepa
Cholesterol-lowering drug needs cardiovascular data (October 16)
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee has voted 9 to 2 against approval of Vascepa (icosapent ethyl, Amarin Corporation) capsules for use as an adjunct to diet and exercise and in combination with a statin in the treatment of adult patients with high triglyceride levels (200–499 mg/dL) with mixed dyslipidemia and coronary heart disease (CHD) or a CHD risk equivalent.
The panel suggested that approval should be withheld pending the results of an 8,000-patient trial that is expected to shed light on whether treatment with Vascepa actually reduces cardiovascular risk. Results of the trial are expected in late 2016.
The FDA is not bound to follow the recommendations of its advisory panels but typically does so. The agency is scheduled to make its final approval decision on December 20, 2013.
Vascepa is a purified ethyl ester of eicosapentaenoic acid (EPA) derived from fish oil. The product is currently approved for use as an adjunct to diet to reduce triglyceride levels in adult patients with severe (= 500 mg/dL) hypertriglyceridemia. The only other approved fish-oil treatment for severe hypertriglyceridemia is Lovaza (omega-3-acid ethyl esters, GlaxoSmithKline).