FDA accepts filing of Epanova for Hypertriglyceridaemia

AstraZeneca has announced that the FDA has accepted for review a New Drug Application (NDA) for Epanova, an investigational compound for the treatment for patients with severe Hypertriglyceridaemia (triglyceride levels greater than or equal to 500mg/dL). The Prescription Drug User Fee Act (PDUFA) goal date for the FDA is 5 May 2014.

The US submission included data from pharmacokinetic and Phase III clinical studies to investigate the safety and efficacy profile of Epanova, a coated soft gelatin capsule containing a complex mixture of polyunsaturated free fatty acids derived from fish oils. In 2012, positive results were reported 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. Both trials were conducted under a Special Protocol Assessment with the US FDA.