FDA to Review Epanova NDA for Severe Hypertriglyceridemia
AstraZeneca announced that the FDA has accepted for review a New Drug Application (NDA) for Epanova, an investigational compound for the treatment of patients with severe hypertriglyceridemia (triglycerides ≥500mg/dL).
The submission was based on data from pharmacokinetic and Phase 3 clinical studies that investigated the safety and efficacy of Epanova. In 2012, positive results were reported 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.
Epanov is a coated soft gelatin capsule containing a complex mixture of polyunsaturated free fatty acids derived from fish oils, including multiple long-chain omega-3 and omega-6 fatty acids, with EPA, DHA, and docosapentaenoic acid being the most abundant forms of omega-3 fatty acids.
For more information call (800) 237-8898 or visit AstraZeneca.com.