Amarin says FDA delays decision on Vascepa trial design

(Reuters) – Amarin Corp Plc said U.S. health regulators delayed their decision to reconsider a rescinded agreement that could support a marketing application for an expanded use of the company’s blood fat-lowering drug. The U.S. Food and Drug Administration had in October revoked a Special Protocol Assessment (SPA) agreement covering a large late-stage trial of the drug, Vascepa. Following an appeal from Amarin, the regulator said it would determine by January 15 whether it would reconsider that decision. …