US Pharm. 2012;37(9):54.
Amarin Corporation plc announced that the FDA has approved Vascepa (icosapentethyl) capsules (formerly known as AMR101) as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe hypertriglyceridemia (very high triglycerides); that is, with TG levels greater than or equal to 500 mg/dL.
The efficacy and safety of Vascepa were assessed in a randomized, placebo-controlled, double-blind, parallel-group study of adult patients with very high fasting triglyceride levels, between 500 mg/dL and 2,000 mg/dL. At baseline, 25% of patients were on concomitant statin therapy, 28% were diabetic, and 39% had TG levels greater than 750 mg/dL. Patients treated for 12 weeks with the 4-g dose of Vascepa demonstrated a statistically significant placebo-adjusted median triglyceride reduction of 33% (P < .001), and did not show an increase in LDL-C levels relative to placebo. Vascepa 4 g/day also showed statistically significant placebo-adjusted median reductions from baseline in non–HDL-C (total cholesterol less “good cholesterol”) of 18%, total cholesterol of 16%, very low density lipoprotein cholesterol (VLDL-C) of 29%, and apolipoprotein B of 9%.
According to Joseph Zakrzewski, chairman and CEO, Amarin expects to launch Vascepa early in the first quarter of 2013.