FDA delays decision on wider use of Amarin’s Vascepa
Amarin Corp Plc’s shares jumped 38 percent following the U.S. Food and Drug Administration’s surprise move to delay a decision on approval for an expanded use of the Irish drugmaker’s blood fat-lowering drug. Analysts expected the FDA to reject the wider use of the drug, Vascepa, after a panel of advisors in October said it should not be approved for a broader population until results from an additional study were analyzed. Amarin’s stock has lost nearly 63 percent of its value since then. The FDA in October also revoked an agreement that guaranteed that the design of a late-stage trial of Vascepa was adequate to support a marketing application.