Under the FDA's special protocol assessment (SPA) for the Anchor indication of Amarin's (AMRN) Vascepa treatment, the agency had said that the design of the associated Phase III trial was adequate to support a marketing application to broaden the use of the drug, which lowers triglyceride fat in blood.
The study was testing Vascepa in people who take statins to cut cholesterol and have a high risk of coronary heart disease. Vascepa is already used to reduce triglycerides in patients who don't take statins.
The FDA is due to decide by December 20 whether to widen the authorization of Vascepa. However, given the latest developments and that an FDA advisory committee overwhelmingly voted against such approval, things are not looking promising.