Amarin Corporation announced that the FDA has approved Vascepa (icosapent ethyl) capsules as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe hypertriglyceridemia (TG ≥500mg/dL).
The efficacy and safety of Vascepa were assessed in Amarin’s MARINE clinical trial, a randomized, placebo-controlled, double-blind, parallel-group study of adult patients with very high fasting triglyceride levels, between 500mg/dL and 2000mg/dL. At baseline, 25% of patients were on concomitant statin therapy, 28% were diabetics, and 39% of patients had TG levels >750mg/dL. Patients treated for 12 weeks with the 4g dose of Vascepa demonstrated a statistically significant placebo-adjusted median triglyceride reduction of 33% (P<0.001), and did not show an increase in LDL-C levels relative to placebo. Vascepa 4g per day also showed statistically significant placebo-adjusted median reductions from baseline in non-HDL-C (total cholesterol less “good cholesterol”) of 18%, Total Cholesterol (TC) of 16%, Very Low Density Lipoprotein Cholesterol (VLDL-C) of 29%, and apolipoprotein B (Apo B) of 9%.
Vascepa (icosapent ethyl) capsules, known in scientific literature as AMR101, is a patented, ultra-pure omega-3 fatty acid product, comprising not less than 96% EPA in a 1g capsule.
For more information call (908) 719-1315 or visit www.amarincorp.com.