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FDA approves Epanova for severe hypertriglyceridemia
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The FDA has approved the use of Epanova, in addition to diet, for the reduction of triglycerides in adults with severe hypertriglyceridemia.
Epanova (omega-3-carboxylic acids, AstraZeneca) is the first omega-3 prescription in free fatty acid form to be approved by the FDA, according to a company press release. It has been approved at a dose of 2 g or 4 g, to be taken orally once per day, with or without food.
The approval follows results from the phase 3 EVOLVE trial, which assessed the efficacy of the treatment for the reduction of triglycerides and other lipid parameters among patients with hypertriglyceridemia.
“The FDA’s 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,” Briggs Morrison, executive vice president of global medicines development and chief medical officer for AstraZeneca, said in a press release. “… We are committed to further assessing the clinical profile of Epanova, and to identifying other patient groups it may benefit.”
The effect of Epanova on CV morbidity and mortality, as well as risk for pancreatitis, is currently unknown. The company will continue to evaluate the effect of Epanova on CV outcomes in patients with mixed dyslipidemia at elevated risk for CVD via the STRENGTH trial, in which participants receive the treatment in combination with statin therapy, according to the release.
AstraZeneca also intends to develop a fixed-dose Epanova/statin combination and will seek approval for the hypertriglyceridemia indication in other markets.