FDA approves prescription fish oil formulation

FDA approves prescription fish oil formulation

August 17, 2012

FDA has approved a prescription fish oil formulation for the treatment of very high levels of triglycerides, according to Amarin, the New Jersey-based biopharmaceutical company that developed the product.

FDA has approved a prescription fish oil formulation for the treatment of very high levels of triglycerides, according to Amarin, the New Jersey-based biopharmaceutical company that developed the product.

Vascepa (icosapent ethyl, formerly known as AMR101) is a patented, ultra-pure omega-3 fatty acid capsule formulation that comprises not less than 96% synthetic ethyl eicosapentaenoic acid in a 1-gram capsule. It is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL), according to Amarin.

The approval follows the release of efficacy and safety data from 2 trials.

In the 12-week, phase 3 MARINE study, in which 25% of patients were on concomitant statin therapy, 28% were diabetic, and 39% had TG levels greater than 750 mg/dL at baseline. After 12 weeks of treatment, patients treated with 4 g of Vascepa had a statistically significant placebo-adjusted median triglyceride reduction of 33% (P < .001) with no increase in low-density lipoprotein cholesterol (LDL-C) levels compared with those treated with placebo. In addition, patients experienced improvements in non-high density lipoprotein cholesterol (non-HDL-C), total cholesterol, and apolipoprotein B.

In the ANCHOR trial, a 12-week multicenter, placebo-controlled, randomized, double-blind study, researchers investigated AMR101 as a treatment for high triglycerides (≥200 and < 500 mg/dL) in patients with mixed dyslipidemia on statin therapy despite LDL-C who were at high risk of cardiovascular disease. The study found that the addition of Vascepa at 4 g/day to statins significantly lowered LDL-C (P=.0067).

"FDA approval of Vascepa represents the introduction of an important new treatment option for patients with severe hypertriglyceridemia," said Joseph Zakrzewski, chairman and CEO of Amarin.

The most commonly reported adverse reaction (incidence > 2% and greater than placebo) in patients treated with Vascepa was arthralgia (2.3% for Vascepa vs 1.0% for placebo).