AstraZeneca target Omthera files for US approval of Epanova

9 July 2013

Emerging US specialty pharmaceutical company Omthera Pharmaceuticals (Nasdaq: OMTH) today announced that it has submitted a New Drug Application to the US Food and Drug Administration seeking approval for the marketing of Epanova, for the treatment for patients with severe hypertriglyceridemia.

The company’s sole product candidate, Epanova is a novel omega-3 free fatty acid composition that has been shown to bolster levels of eicosapentenoic acid and docosahexenoic acid significantly in the blood.

The FDA submission is based on the entire data set from Omthera's clinical development program, specifically positive results from two Phase III trials (EVOLVE and ESPRIT) examining the effectiveness of Epanova in lowering very high triglycerides, and in reducing non-HDL cholesterol in combination with a statin for patients with high triglycerides. Both trials were conducted under a Special Protocol Assessment with the US FDA.

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