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news.The US Food and Drug Administration (FDA) has approved AstraZeneca's EPANOVA (omega-3-carboxylic acids) to use as an adjunct to diet to reduce triglyceride levels in adults with severe hypertriglyceridaemia.
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Triglycerides are a type of fat found in blood and an important energy source for the body.
According to the company, EPANOVA is the first FDA approved prescription omega-3 in free fatty acid form.
The company said that 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.
AstraZeneca executive vice president of Global Medicines Development and chief medical officer Briggs Morrison said the FDA’s approval of EPANOVA is good news for the significant and growing population with severe hypertriglyceridaemia as it offers physicians and their patients an important new treatment option that has been proven to be effective in clinical trials.
"This approval is a significant milestone for AstraZeneca, as it strengthens our existing portfolio of cardiovascular medicines," Morrison said.
"We are committed to further assessing the clinical profile of EPANOVA and to identifying other patient groups it may benefit."
EPANOVA is a pure, free fatty acid form that can provide physicians with an option to effectively manage the condition without increasing a patient’s pill burden.
The approval was based on data from a clinical development program that included positive results from the Phase III EVOLVE trial, which evaluated the efficacy of the drug in lowering triglycerides and other key lipid parameters in patients with very high triglycerides.
The company said that the effect of EPANOVA on the risk of pancreatitis or on cardiovascular mortality and morbidity has not been determined.
Image: AstraZeneca Headquarters in London, United Kingdom. Photo: courtesy of AstraZeneca.