FDA Approves Epanova for Severe Hypertriglyceridemia

The US Food and Drug Administration (FDA) has approved omega-3 carboxylic acids (Epanova , AstraZeneca) for use as an adjunct to diet to reduce triglyceride levels in adults with severe hypertriglyceridemia (triglyceride levels >500 mg/dL), a condition that affects around 4 million Americans.

The approval was based on data from the phase 3 Epanova for Lowering Very High Triglycerides (EVOLVE) trial, which examined the efficacy of the product in lowering triglycerides and other key lipid parameters in patients with very high triglycerides.

Epanova will be the third prescription formulation of an omega-3 polyunsaturated fatty-acid (PUFA) product approved in the United States for the treatment of hypertriglyceridemia.

It is the first FDA-approved prescription omega-3 in free fatty-acid form, the company notes. The approved dose is 2 g (2 capsules) or 4 g (4 capsules), making it the first prescription omega-3 product to have a dosing option as few as 2 capsules, once a day, which can be taken with or without food.

Amarin's synthetic ethyl eicosapentaenoic acid (EPA), icosapent ethyl (Vascepa), was given the FDA nod 2 years ago, andLovaza (GlaxoSmithKline), which contains a combination of ethyl esters of omega 3 fatty acids, principally EPA and docosahexaenoic acid (DHA), has been available for the same indication for a number of years.

AstraZeneca says it plans to file for regulatory approval of Epanova for severe hypertriglyceridemia in other markets.

Race to Gain Approval in Conjunction With Statins

AstraZeneca is also hoping to succeed where others have failed in gaining approval of Epanova in conjunction with use of statins for the much wider indication of mixed dyslipidemia; a study in this patient population, called Statin Residual Risk Reduction With Epanova in High Cardiovascular Risk Patients With Hypertriglyceridemia (STRENGTH), is planned in around 13,000 patients, and the company says it will pursue development of a fixed-dose combination of Epanova with a statin .

Last year, the FDA rejected Amarin's application for expanded approval of Vascepa based on the results of the ANCHOR trial in the same patient population.

Amarin is now examining Vascepa combined with statin therapy in a larger trial, in around 8000 patients, called Reduction of Cardiovascular Events With EPA—Intervention Trial (REDUCE-IT).

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