The US Food and Drug Administration (FDA) has accepted to review AstraZeneca's new drug application (NDA) for Epanova, an investigational compound for the treatment for patients with severe hypertriglyceridaemia.
Omthera Pharmaceuticals, a subsidiary of AstraZeneca, and developer of Epanova has filed its NDA submission in July 2013, for which FDA will make a decision on its approval by 05 May 2014.
Epanova is a coated soft gelatin capsule containing a complex mixture of polyunsaturated free fatty acids derived from fish oils.
The NDA included data from pharmacokinetic and Phase III clinical studies conducted to investigate the safety and efficacy profile of Epanova.
The submission was based around two Phase III studies, which examined the effectiveness of the drug in lowering very high triglycerides and in reducing non-HDL cholesterol in combination with a statin for patients with high triglycerides.
Hypertriglyceridaemia is a serum lipid disorder defined by serum triglyceride levels of =150 mg/dL and is related with an increased risk of cardiovascular diseases, such as coronary artery disease, or acute risk of pancreatitis if triglyceride levels exceed 500 mg/dL.
