Amarin, a biopharmaceutical company, has announced the outcome of the US Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee for the use of Vascepa (icosapent ethyl) capsules in the treatment of high triglycerides with mixed dyslipidemia.
Amarin has announced that the 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 (TG 200-499 mg/dL) with mixed dyslipidemia and coronary heart disease (CHD) or a CHD risk equivalent (the ANCHOR indication) based on the information presented at the committee meeting today.
The FDA is scheduled to make its decision on whether to approve the ANCHOR supplemental new drug application on the 20 December 2013 Prescription Drug User Fee Act (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 ( >= 500 mg/dL) hypertriglyceridemia.
Vascepa, known in scientific literature as AMR101, is a patented, pure-EPA omega-3 prescription product in a 1 gram capsule.