WILMINGTON, Del. — AstraZeneca on Tuesday announced the Food and Drug Administration approved Epanova (omega-3-carboxylic acids) 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 FDA approval of Epanova is good news for the significant and growing population with severe hypertriglyceridemia as it offers physicians and their patients an important new treatment option that has been proven to be effective in clinical trials," stated Briggs Morrison, EVP global medicines development and chief medical officer, AstraZeneca. "This approval is a significant milestone for AstraZeneca, as it strengthens our existing portfolio of medicines. We are committed to further assessing the clinical profile of Epanova and identifying other patient groups it may benefit."
Epanova is the first FDA approved prescription omega-3 in free fatty acid form, AstraZeneca reported. 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. It can be taken with or without food.
"Patients with severe hypertriglyceridemia often have other medical conditions, such as diabetes and high blood pressure, that require them to take multiple medications," added Michael Davidson, EVP of Omthera Pharmaceuticals, an AstraZeneca company. "Although physicians will treat each patient individually, Epanova offers physicians a two-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 two gram dose."