July 27th, 2012
FDA Approves New Prescription Fish Oil Pill
The FDA has approved a new prescription formulation of fish oils for treating very high triglyceride levels.
The drug will be sold under the brand name Vascepa. According to Amarin, the manufacturer, it will be indicated as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia (>500 mg/dL).
Vascepa contains ultra-purified ethyl EPA, an omega-3 fatty acid. Vascepa will be the second prescription fish oil formulation, following GlaxoSmithKline’s Lovaza.
The triglyceride-lowering efficacy of Vascepa has been studied in two 12-week, placebo-controlled phase 3 studies: ANCHOR, in patients with triglyceride levels between 200 and 500 mg/dL; and MARINE, in patients with triglyceride levels between 500 and 2000 mg/dL. Last year Amarin announced the commencement of REDUCE-IT (Reduction of Cardiovascular Events with EPA – 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.
A recent meta-analysis of studies with 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.
Click here to read the press release from Amarin.
Click here to read prescribing information for Vascepa.