AstraZeneca wins FDA approval of Epanova drug

6th May 2014 07:48

The US Food and Drug Administration (FDA) has granted approval of Epanova, AstraZeneca's treatment for adults with the condition hypertriglyceridemia. The drug is designed to be used in conjunction with diet to reduce the level of triglycerides, the most common type of fatty acid found in blood. In people with hypertriglyceridemia this level is too high and is often associated with conditions such as obesity and diabetes. "The FDA's approval of Epanova is good news for the significant and growing population with severe hypertriglyceridaemia as it offers physicians and their patients an important new treatment option that has been proven to be effective in clinical trials," said Briggs Morrison, the Executive Vice President of Global Medicines Development and Chief Medical Officer at AstraZeneca. "This approval is a significant milestone for AstraZeneca, as it strengthens our existing portfolio of cardiovascular medicines. We are committed to further assessing the clinical profile of Epanova and to identifying other patient groups it may benefit."The treatment is a pure, free fatty acid form that can provide physicians with an option to effectively manage the condition without dramatically increasing a patient's pill burden, AstraZeneca further explained. It is now continuing to evalute the drug's clinical profile and plans to examine the safety and efficacy of Epanova on cardiovascular outcomes in combination with statin therapy in patients with mixed dyslipidaemia who are at increased risk of cardiovascular disease. The group also plans to pursue the development of a fixed dose combination of the drug with a statin and plans to file for regulatory approval in other markets for the severe hypertriglyceridaemia indication. NR