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.

3 Responses to “FDA Approves New Prescription Fish Oil Pill”

  1. Leon Hyman, Ms M.D. says:

    This whole thing seems fishy to me. Does it have any advantage over mercury free salmon oil caps sold at Costco which are inexpensive and will it alter clinical outcomes?

  2. David Powell , MD, FACC says:

    I heard the relevant information from the company. The currently approved DHA/EPA combo (“lovaza”) is approved on the basis of surrogates only (trig level). No outcome data. Pure EPA has better surrogates, as LDL does not increase, CRP and non- HDL colesterol goes down…
    So thats pretty much it. The company talks about a large outcome trial with background high dose statin therapy as above: REDUCE – IT. Must enroll a lot of patients to power it! This is high dose EPA ..4 tabs daily (available in Japan)

  3. This is one of those relatively unusual cases in which a prescription version of an OTC drug or supplement has been produced. As a result, there are two particularly important questions: (a) Do n-3 fatty acids reduce triglycerides and/or cardiovascular events; and (b) Is Vascepa superior to the widely available OTC versions of EPA? The first question is addressed in numerous studies, and the literature is quite mixed. For example, the Koh et al. study published last year in Atherosclerosis, confirmed the value of n-3 fatty acids in reducing triglycerides, but also showed that fenofibrates are more effective. However, the ORIGIN trial, published last month in NEJM showed no reduction of cardiovascular events in those taking n-3 fatty acids. The second question remains unanswered, except in Amarin’s MARINE trial. In fact, Amarin says on its website that the effectiveness of Vascepa has not been determined. As a result, we may find that the FDA has approved a drug/supplement that has no clearly demonstrated efficacy in reducing triglycerides or cardiovascular events or that the Vascepa is no more effective than its OTC counterparts.