BETHESDA, MD 27 July 2012—Amarin Corporation plc of Dublin, Ireland, on July 26 announced the U.S. approval of icosapent ethyl oral capsules, as an adjunct to diet, for the reduction of triglyceride levels in adults with hypertriglyceridemia.
The company will market icosapent as Vascepa and plans to launch the product in the United States early next year.
According to the labeling (PDF) for icosapent, the drug is indicated for use in patients with severe trihyperglyceridemia, defined as a serum triglyceride level of ≥500 mg/dL.
The labeling recommends placing patients "on an appropriate lipid-lowering diet and exercise regimen" before initiating treatment with icosapent and continuing the regimen during therapy.
Before adding icosapent to a patient's medication regimen, other therapies that are known to worsen hypertriglyceridemia, such as beta-blockers, thiazides, and estrogens, should be reevaluated and changed or discontinued, the labeling states.
The patient's treatment plan should include an effort should to manage medical problems such as diabetes mellitus, hypothyroidism, and alcohol-related dyslipidemia.
The recommended dosage of icosapent is two 1-g capsules taken twice daily with food.
Patients with impaired liver function should have their serum transaminase levels monitored periodically during treatment with icosapent.
Icosapent contains ethyl esters of fish-oil-derived eicosapentaenoic acid and should be used with caution in patients who are allergic to fish or shellfish. Because some clinical studies have indicated that omega-3 fatty acids from fish oil may prolong bleeding times, coagulation should be monitored periodically in patients treated with icosapent and other drugs that affect clotting.
In clinical trials, the most common adverse events associated with the use of icosapent were joint pain and stiffness.
Icosapent was not studied in clinical trials involving patients with liver or kidney impairment. It is not known whether icosapent therapy affects the risk for pancreatitis or cardiovascular-related illness and death in patients with severe hypertriglyceridemia.
Icosapent will be supplied in bottles of 120 1-g capsules. The bottles should be stored at controlled room temperature.