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Icosapent ethyl capsules gain FDA approval for reduction of triglycerides
Amarin today announced that its icosapent ethyl capsules received FDA approval for the reduction of triglycerides in adults with severe hypertriglyceridemia.
Icosapent ethyl (Vascepa), formerly known as AMR101, is indicated as an adjunct to diet for adults with triglyceride levels that exceed 500 mg/dL. The daily dose is 4 g administered orally, according to a press release.
Approval was based on results from the randomized, double blind, placebo-controlled, parallel-group MARINE trial. Data showed that adults with hypertriglyceridemia treated for 12 weeks with the 4-g dose demonstrated a significant placebo-adjusted mean triglyceride reduction of 33% and did not show an increase in LDL levels relative to placebo. The 4-g dose also successfully reduced non-HDL by 18%, total cholesterol by 16%, very low density lipoprotein by 29% and apolipoprotein B by 9%, according to information in the release.
Icosapent ethyl is an ultra-pure omega-3 fatty acid product comprising not less than 96% EPA in a 1-g capsule.
Commercial launch is anticipated in the first quarter of 2013, according to Amarin.