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.