FDA approves Epanova for treatment of Hypertriglyceridaemia-AstraZeneca
AstraZeneca has announced that the FDA has approved Epanova (omega-3-carboxylic acids) as an adjunct to diet to reduce triglyceride levels in adults with severe Hypertriglyceridaemia (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 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.
The FDA approval was based on data from a clinical development programme that included positive results from the Phase III EVOLVE (EpanoVa fOr Lowering Very High triglyceridEs) trial, which examined the efficacy of Epanova in lowering triglycerides and other key lipid parameters in patients with very high triglycerides. The effect of Epanova on the risk of pancreatitis or on cardiovascular mortality and morbidity has not been determined.
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