As part of this filing, Reliant submitted new data from the recently completed trial that evaluated the efficacy and safety of Omacor as an adjunct to diet and simvastatin therapy for the treatment of high triglycerides.
“By seeking this expanded indication, Omacor may serve as a safe, new treatment option for adults whose triglyceride levels remain high in spite of statin therapy,” said Steven Ketchum, senior vice president, R&D, Reliant Pharmaceuticals.
Omacor is the first and only FDA-approved, prescription omega-3 fatty acid product, and has been proven safe and effective in clinical studies as an adjunct to diet to reduce very high triglycerides in adult patients. Omacor was originally granted FDA approval in 2004.
Omacor contains the key omega-3 components, eicosapentaenoic acid and docosahexaenoic acid to reduce very high triglycerides, and is naturally derived through a patented process that creates a highly concentrated and purified prescription medicine. A high triglyceride level causes a condition known as hypertriglyceridemia, which is linked to the occurrence of heart disease in some people.