Cor Integrilin confirmatory trial necessary for PTCA approval, committee says.Page 2
Executive Summary
COR INTEGRILIN CONFIRMATORY TRIAL NECESSARY FOR APPROVAL of the glycoprotein IIb/IIIa inhibitor, FDA's Cardiovascular & Renal Drugs Advisory Committee concluded at its Feb. 28 meeting. The committee voted 6-2 that the IMPACT-II trial showed positive results for Integrilin as adjunctive therapy in patients undergoing PTCA for prevention of acute cardiac ischemic complications, but members unanimously agreed that the IMPACT-II trial alone is insufficient to show clinical benefit.