AstraZeneca announced that it has received US Food and Drug Administration (FDA) approval for Epanova (omega-3-carboxylic acids) as an adjunct treatment to a proper diet in the reduction of triglyceride levels in adults with severe hypertriglyceridemia.
Almost 4 million adults in the U.S. have severe hypertriglyceridemia, in which fat accumulates in the blood and leads to serious health complications. Triglycerides are a type of lipid that resides in the blood and provides energy to the body. The number of people with severe hypertriglyceridemia continues to rise along with the incidence of related conditions such as diabetes and obesity.
Dr. Michael Davidson, EVP of Omthera Pharmaceuticals, an AstraZeneca company, said, “Patients with severe hypertriglyceridemia often have other medical conditions, such as diabetes and high blood pressure, which require them to take multiple medications. Although physicians will treat each patient individually, EPANOVA offers physicians a two-capsule dosing option, once a day with or without food. This provides physicians with a simple, patient-friendly option to effectively manage this serious condition without dramatically increasing a patient’s pill burden when prescribing the two gram dose.”
Epanova is the first prescription omega-3 in free fatty acid form approved by the FDA. The drug’s dosage of 2 grams (2 capsules) and 4 grams (4 capsules) provides patients with a dosing option of as few as two capsules once a day.
Dr. Briggs Morrison, EVP of Global Medicines Development and CMO of AstraZeneca, said the approval brings new medication options for the increasing number of people afflicted with severe hypertriglyceridemia. “We are committed to further assessing the clinical profile of EPANOVA and identifying other patient groups it may benefit,” said Dr. Morrison.
The FDA approval of Epanova was supported by data from a clinical development program that boasted positive results from the Phase III EVOLVE (EpanoVa fOr Lowering Very high triglyceridEs) trial. The company said it will further investigate the drug’s clinical profile in the large scale STRENGTH (a long–term outcomes study to assess STatin Residual risk reduction with EpaNova in hiGh cardiovascular risk paTients with Hypertriglyceridemia) trial. STRENGTH will assess the drug’s safety and efficacy on cardiovascular outcomes in combination with statin therapy in patients with mixed dyslipidemia at higher risk of cardiovascular disease.
The company also announced it intends to submit application for regulatory approval for Epanova in other markets for the indication of severe hypertriglyceridemia.