FDA Approves Omega-3 Therapy for High Triglycerides

The FDA has approved AstraZeneca’s Epanova, (omega-3-carboxylic acids) a treatment to help reduce triglyceride levels in adults with severe hypertriglyceridemia (triglyceride levels greater than or equal to 500 mg/dL). Epanova is the first FDA-approved prescription omega-3 in free fatty acid form.

The FDA approval was based on data from a clinical development program that included positive results from the Phase III trial, which examined the efficacy of Epanova in lowering triglycerides and other key lipid parameters in patients with high triglycerides. The effect of Epanova on the risk of pancreatitis or on cardiovascular mortality and morbidity has not been determined.

AstraZeneca continues to assess the impact of lowering triglycerides and further evaluate the clinical profile of Epanova. Through a large-scale trial, AstraZeneca will evaluate the safety and efficacy of Epanova on cardiovascular outcomes in combination with statin therapy in patients with mixed dyslipidemia at increased risk of cardiovascular disease. The company also plans to pursue the development of a fixed dose combination of Epanova with a statin and plans to file for regulatory approval in other markets for the severe hypertriglyceridemia indication.