FDA Accepts New Drug Application for Epanova for Treatment of Severe Hypertriglyceridemia
Approval decision expected in May 2014 (September 18)
The FDA has accepted for review a New Drug Application (NDA) for Epanova (Omthera Pharmaceuticals/AstraZeneca), an investigational compound for the treatment of patients with severe hypertriglyceridemia (i.e., triglyceride levels greater than or equal to 500 mg/dL).
The FDA’s Prescription Drug User Fee Act (PDUFA) goal date is May 5, 2014.
The U.S. submission included data from phase III clinical studies that investigated the safety and efficacy of Epanova, a coated soft-gelatin capsule containing a mixture of polyunsaturated free fatty acids derived from fish oils. In 2012, positive results were reported from two phase III trials (EVOLVE and ESPRIT) that examined the effectiveness of Epanova in lowering very high triglycerides and in reducing non–high-density lipoprotein (HDL) cholesterol in combination with a statin for patients with high triglycerides.
Epanova is an investigational mixture of the free fatty acid forms of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). The drug is designed to reduce triglycerides and to improve other key lipid parameters. It is administered at a dosage of 2 grams once daily with or without meals.
Source: AstraZeneca; September 18, 2013.