FDA panel not swayed by Vascepa’s results

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 - Thumbs down, rejection

An advisory committee for the FDA voted 9-2 against recommending approval of an expanded indication for Vascepa, a patented omega-3 fatty acid product.

The FDA approved Vascepa in July 2012 in combination with diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia. The manufacturer Amarin had sought an expanded use for Vascepa in combination with a statin as a treatment for patients with high triglycerides with mixed dyslipidemia and coronary heart disease or a coronary heart disease risk equivalent.

Endocrinologic and Metabolic Drugs Advisory Committee members reviewed results from ANCHOR, a multicenter, placebo-controlled, randomized, double-blinded clinical trial. The study found that triglyceride levels decreased 21.5 percent in patients treated for 12 weeks with 4 g Vascepa daily compared with placebo.

Despite the positive findings, the panel overwhelming opposed approval. Amarin, which is based in Bedminster, N.J., and Dublin, Ireland, said the FDA is scheduled to make its decision Dec. 20. The FDA usually, but not always, follows the recommendations of its panels.