- 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- The FDA had originally allowed the SPA, but rescinded it in October, saying that it would no longer consider a change in serum triglyceride levels as enough evidence to show efficacy.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.
- Shares plummet 26%. (PR)
FDA division won't reinstate SPA for Amarin's Vascepa
Jan 21 2014, 07:47 ET