The FDA has approved a new prescription formulation of fish oils for the treatment of very high levels of triglycerides. The news was first reported by The Street reporter Adam Feuerstein.
The drug will be sold under the brand name Vascepa. According to the company, it will be indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe hypertriglyceridemia (TG > 500mg/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, which Feuerstein said generates about $1 billion in annual sales.
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), a 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.