The FDA has approved a new prescription formulation of fish oils for treating very high triglyceride levels.<\/p>\n
The drug will be sold under the brand name Vascepa. According to Amarin, the manufacturer, it will be indicated\u00a0as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia (>500 mg\/dL).<\/p>\n
Vascepa contains\u00a0ultra-purified ethyl EPA, an omega-3 fatty acid. Vascepa will be the second prescription fish oil formulation, following GlaxoSmithKline’s Lovaza.<\/p>\n
The triglyceride-lowering efficacy of Vascepa has been studied in two 12-week, placebo-controlled phase 3 studies:\u00a0ANCHOR<\/a>, in patients with triglyceride levels between 200 and 500 mg\/dL; and\u00a0MARINE<\/a>, in patients with triglyceride levels between 500 and 2000 mg\/dL.\u00a0Last year Amarin announced the commencement of\u00a0REDUCE-IT<\/a>\u00a0(Reduction of Cardiovascular Events with EPA \u2013 Intervention Trial), designed to evaluate the efficacy of Vascepa when given in addition to a statin in reducing major cardiovascular events in a high-risk population.<\/p>\n A recent meta-analysis of studies<\/a>\u00a0with various preparations of fish oils found no evidence of a reduction in cardiovascular events with fish oil supplements in patients with a history of cardiovascular disease.<\/p>\n Click\u00a0here<\/a>\u00a0to read the press release from Amarin.<\/p>\n