Amarin Corporation plc, Bedminster, NJ and Dublin, Ireland, has announced that the U.S. Food and Drug Administration (FDA) has approved Vascepa (icosapent ethyl) capsules, as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe hypertriglyceridemia. Amarin submitted the New Drug Application for the use of Vascepa in this indication in September 2011. The efficacy and safety of Vascepa was assessed in a clinical, randomized, placebo-controlled, double-blind, parallel-group study of adult patients with very high fasting triglyceride levels, between 500 mg/dL and 2000 mg/dL. At baseline, 25% of patients were on statins, 28% were diabetics, and 39% of patients had TG levels greater than 750 mg/dL. Patients treated for 12 weeks with the 4 gram dose of Vascepa demonstrated a statistically significant placebo-adjusted median triglyceride reduction of 33%, and did not show an increase in LDL-C levels relative to placebo.