AstraZeneca has obtained approval from the US Food and Drug Administration (FDA) for Epanova (omega-3-carboxylic acids) for treatment of adults with severe hypertriglyceridaemia.
Epanova is designed to use an adjunct to diet to reduce the levels of triglycerides, the most common type of fatty acid found in blood, in adults with severe hypertriglyceridaemia (triglyceride levels greater than or equal to 500mg/dL).
According to AstraZeneca, Epanova is the first FDA-approved prescription omega-3 in free fatty acid form.
The FDA approved Epanova based on data from pharmacokinetic and Phase III clinical studies that investigated the safety and efficacy profile of the drug.
Positive results were reported in 2012 from two Phase III trials (EVOLVE and ESPRIT) evaluating 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.
The effect of Epanova on the risk of pancreatitis or on cardiovascular mortality and morbidity has not been determined.
AstraZeneca chief medical officer global medicines development executive vice-president Briggs Morrison said that Epanova offers physicians and patients an important new treatment option for hypertriglyceridaemia.
"This approval is a significant milestone for AstraZeneca, as it strengthens our existing portfolio of cardiovascular medicines," Morrison said. "We are committed to further assessing the clinical profile of Epanova and to identifying other patient groups it may benefit."
Developed by Omthera Pharmaceuticals, Epanova 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. The most abundant forms of omega-3 fatty acids are eicosapentaenoic acid, docosahexaenoic acid, and docosapentaenoic acid.
Epanova reduces triglycerides and improves other key lipid parameters. It is expected to increase patient convenience with 2g once-a-day dosing with or without meals.
Omthera Pharmaceuticals, now a wholly owned subsidiary of AstraZeneca, had filed a new drug application (NDA) with the FDA in July 2013 for Epanova for the treatment for patients with severe hypertriglyceridaemia. In September 2013, the FDA accepted to review the NDA for Epanova.
Image: AstraZeneca’s head office in London, UK. Photo: courtesy of AstraZeneca plc.