NDA Submitted for Epanova for Severe Hypertriglyceridemia
Omthera Pharmaceuticals announced that it has submitted a New Drug Application (NDA) to the FDA seeking approval for the marketing and sale of Epanova for the treatment of patients with severe hypertriglyceridemia (TG ≥500mg/dL). Epanova is a novel, ultra-pure mixture of the free fatty acid forms of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). It reduces triglycerides, improves other key lipid parameters and is expected to increase patient convenience with a 2g once-a-day dosing with or without meals.
The submission is based on the entire data set from Omthera's clinical development program, specifically positive results from two Phase 3 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.For more information call (908) 741-4399 or visit www.omthera.com.