FDA approves omega-3 fatty acid drug for very high triglycerides

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The FDA has approved Amarin's icosapent ethyl (Vascepa) capsules (formerly known as AMR101) as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia (triglyceride levels greater than or equal to 500mg/dL).

Amarin submitted the new drug application for the use of Vascepa in this indication in September 2011. The drug, according to the Bedminster, N.J.-based company, is a patented omega-3 fatty acid product.

The safety information included in the labeling is:
  • The effect of Vascepa on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.
  • The effect of Vascepa on cardiovascular mortality and morbidity in patients with severe hypertriglyceridemia has not been determined.
  • Vascepa is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to Vascepa or any of its components.
  • Use with caution in patients with known hypersensitivity to fish and/or other shellfish.
  • The most common reported adverse reaction (incidence more than 2 percent and greater than placebo) was arthralgia.
  • Patients should be advised to swallow Vascepa capsules whole; not to break open, crush, dissolve, or chew Vascepa.

Amarin plans to commercially launch Vascepa early in the first quarter of 2013, Joseph Zakrzewski, chairman and CEO of Amarin, said in a statement.

The approval of the drug was based on the efficacy and safety findings in the MARINE clinical trial, 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.