Weighing Benefits and Risks — The FDA's Review of Prasugrel

Abstract

The Food and Drug Administration (FDA) approved prasugrel on July 10, 2009. Developed by Eli Lilly and Daiichi Sankyo, prasugrel is a thienopyridine that inhibits platelet aggregation. It was approved for the reduction of thrombotic cardiovascular events in patients with acute coronary syndrome (unstable angina or myocardial infarction) who undergo percutaneous coronary intervention (PCI). The FDA grappled with a number of complex issues during the review process,1 and the application was presented to the Cardiovascular and Renal Drugs Advisory Committee on February 3, 2009.2 The Trial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibition with Prasugrel–Thrombolysis in Myocardial . . .