A panel of experts to the U.S. FDA recommended allowing Amarin Corp Plc’s fish-oil derived drug to be used as an add-on therapy for reducing the chance of heart attacks and strokes in high-risk patients with cardiovascular disease. The panel on Thursday voted 16-0 in favor of expanding approval, potentially opening up a multi-billion dollar opportunity for the company which has only one drug, Vascepa, in the market. The FDA, which is slated to announce its final decision on the label expansion by Dec. 28, is not mandated to follow the recommendation of the panel, but generally does. …read more
Source:: Yahoo Finance