Amarin Corp. plc (AMRN), biopharmaceutical company, announced that the U.S. Food and Drug Administration or FDA Endocrinologic and Metabolic Drugs Advisory Committee has voted 9 to 2 against approval of Vascepa capsules for use as an adjunct to diet and exercise and in combination with a statin in the treatment of adult patients with high triglycerides with mixed dyslipidemia and coronary heart disease or CHD or a CHD risk equivalent based on the information presented at the committee meeting.
The company said the FDA is scheduled to make its decision on whether to approve the ANCHOR Supplemental New Drug Application or sNDA on the December 20, 2013 Prescription Drug User Fee Act or PDUFA goal date for the application.
Vascepa is currently approved by the FDA for use as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia, Amarin noted.
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