Supplier News Breaks Archives
AstraZeneca omega-3 capsule approved by FDA
May 6th, 2014
WILMINGTON, Del. – AstraZeneca has received approval from the Food and Drug Administration for Epanova (omega-3-carboxylic acids), indicated 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 maker said Tuesday that Epanova marks the first FDA-approved prescription omega-3 in free fatty acid form.
The dosage of Epanova is 2 grams (two capsules) or 4 grams (four capsules), making it the first prescription omega-3 to have a dosing option as few as two capsules once a day, AstraZeneca noted. The capsule can be taken with or without food.
"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, executive vice president, global medicines developmen, and chief medical officer at 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."
Triglycerides are a type of lipid, or fat, found in blood and a key energy source for the body. Some people have very high triglyceride levels (severe hypertriglyceridemia), or too much fat in their blood, which can lead to serious health complications. Almost 4 million U.S. adults currently have severe hypertriglyceridemia, AstraZeneca reported, and that figure continues to rise, along with the incidence of related conditions, such as obesity and diabetes.
"Patients with severe hypertriglyceridemia often have other medical conditions, such as diabetes and high blood pressure, that require them to take multiple medications," explained Michael Davidson, executive vice president at 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."