The Food and Drug Administration ( 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.
Triglycerides are a type of lipid found in blood and an essential energy source for the body. Some people have very high triglyceride levels ( severe hypertriglyceridaemia ), meaning they have too much fat in their blood which can lead to serious health complications.
Nearly four million American adults currently have severe hypertriglyceridaemia and this figure continues to rise, as the prevalence of associated conditions, such as obesity and diabetes, continues to grow.
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. ( Xagena )
Source: AstraZeneca, 2014