Epanova
Generic name:omega-3-carboxylic acids
Drug class:Nutraceutical products
Approval date: May 5, 2014
Company: AstraZeneca
Medically reviewed by Drugs.com. Last updated on May 18, 2022.
Treatment for: Hypertriglyceridemia
The Epanova brand name has been discontinued in the U.S. If generic versions of this product have been approved by the FDA, there may be generic equivalents available.
FDA Approves Epanova
The United States Food and Drug Administration (FDA) has approved AstraZeneca’s Epanova (omega-3-carboxylic acids) in conjunction with diet to treat severe hypertriglyceridemia in adults. Hypertriglyceridemia condition characterized by high levels of triglycerides in the blood, and while an essential energy source for the body, high triglyceride levels can lead to serious health complications. Hypertriglyceridemia is considered severe when triglyceride levels are greater than or equal to 500 mg/dL.
Epanova is the first FDA approved prescription omega-3 in free fatty acid form. It is derived from fish oil and consists of an ultra-pure mixture of the free fatty acids docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA). Similar prescription drugs used in the treatment of hypertriglyceridemia include Lovaza (omega-3-acid ethyl esters) and Vascepa (icosapent ethyl). Generic versions of Lovaza were approved in April 2013.
The FDA approval was based on data from a that included positive results from the Phase III EVOLVE (EpanoVa fOr Lowering Very High triglyceridEs) trial. AstraZeneca is continuing to evaluate the clinical profile of Epanova through a large-scale cardiovascular outcomes trial, STRENGTH (STatin Residual risk reduction with EpaNova in hiGh cardiovascular risk paTients with Hypertriglyceridemia) in combination with statin therapy. The company's statin product Crestor (rosuvastatin) holds a large market share and may be developed further as a fixed dose combination with Epanova.
The dosage of Epanova is 2 grams (2 capsules) or 4 grams (4 capsules), making it the first prescription omega-3 to have a dosing option as few as two capsules once a day, with or without food.
Epanova Patient Information
Read this Patient Information before you receive this medicine and each time you receive treatment. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.
