Omthera Pharma files Epanova with the FDA for treating Hypertriglyceridemia

Omthera Pharmaceuticals has submitted a New Drug Application (NDA) to the FDA seeking approval for the marketing and sale of Epanova (EPA and DHA) for the treatment for patients with severe Hypertriglyceridemia (triglyceride levels greater than or equal to 500mg/dL). The submission is based on the data set from Omthera's clinical development program, specifically positive results from two Phase III trials (EVOLVE and ESPRIT) examining the effectiveness of Epanova in lowering very high triglycerides, and in reducing non-HDL cholesterol in combination with a statin for patients with high triglycerides.

Hypertriglyceridemia refers to a condition in which patients have high blood levels of triglyceridesand is associated with increased risk of heart disease. It is one component of a range of lipid disorders collectively referred to as Dyslipidemia.