Omthera's Epanova meets hypertriglyceridemia endpoint

Omthera Pharmaceuticals Inc. (Bedminster, N.J.) said once-daily 2, 3 and 4 g doses of Epanova all met the primary endpoint of reducing triglyceride levels from baseline to week 12 vs. placebo in the Phase III EVOLVE trial to treat hypertriglyceridemia. Specifically, 2 and 4 g Epanova led to median reductions in triglycerides of 26% and 31%, respectively. Additionally, 2 and 4 g Epanova each reduced non-HDL-C, a secondary endpoint, by 8% from baseline to week 12. Data for the 3 g dose of Epanova were not disclosed. The double-blind, international trial enrolled 399 patients with triglyceride levels of 500-2,000 mg/dL. Epanova is an ultra-pure mixture of the free fatty acid forms of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). Placebo was olive oil.

Data from the Phase III ESPRIT trial evaluating Epanova as an add-on to statin therapy in 647 patients with hypertriglyceridemia are expected in July. ...