Vascepa Approved for Severe Hypertriglyceridemia

VASCEPA (icosapent ethyl) 1g capsules by Amarin
VASCEPA (icosapent ethyl) 1g capsules by Amarin

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.

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