Drug for severe hypertriglyceridemia approved

May 7, 2014

FDA approved omega-3-carboxylic acids (Epanova, AstraZeneca) as an adjunct to diet to reduce triglyceride levels in adults with severe hypertriglyceridemia (triglyceride levels greater than or equal to 500 mg/dL).

FDA approved omega-3-carboxylic acids (Epanova, AstraZeneca) as an adjunct to diet to reduce triglyceride levels in adults with severe hypertriglyceridemia (triglyceride levels greater than or equal to 500 mg/dL). 

The drug is the first FDA-approved prescription omega-3 in free fatty acid form. The dosage of omega-3-carboxylic acids is 2 g (2 capsules) or 4 g (4 capsules), making it the first prescription omega-3 to have a dosing option as few as 2 capsules once a day, with or without food.

“The approval of [omega-3-carboxylic acids] is most important for the patients with severe hypertriglyceridemia and the physicians who treat them,” said  Laurie Casaday, director, brand corporate affairs, AstraZeneca. “Although physicians will treat each patient individually [omega-3-carboxylic acids], offers physicians a 2-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 2-g dose.”

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 hypertriglyceridemia), meaning they have too much fat in their blood, which can lead to serious health complications.

Currently, about 4 million American adults have severe hypertriglyceridemia and this number continues to rise, as the prevalence of associated conditions, such as obesity and diabetes, continues to grow.

FDA approval was based on data from a clinical development program that included positive results from the phase 3 EVOLVE (EpanoVa fOLowering Very High triglyceridEs) trial, which examined the efficacy of omega-3-carboxylic acids in lowering triglycerides and other key lipid parameters in patients with very high triglycerides. The effect of omega-3-carboxylic acids on the risk of pancreatitis or on cardiovascular mortality and mo rbidity has not been determined.