The FDA's Division of Metabolism & Endocrinology Products has told Amarin (AMRN) that it doesn't plan to reinstate a special protocol assessment agreement (SPA) for a trial related to the expanded use of the biopharmaceutical firm's Vascepa drug.
Amarin intends to appeal the decision to the FDA's director of the Office of Drug Evaluation II.
The FDA had originally allowed the SPA, but rescinded it in October, saying that it would no longer consider a change in serum triglyceride levels as enough evidence to show efficacy.
Under the new "ANCHOR" indication, the therapy would be used to treat people who take statins to cut cholesterol and have a high risk of coronary heart disease.
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