A US Food and Drug Administration advisory panel voted unanimously to recommend approval of prasugrel (Lilly/Daiichi Sankyo) for the treatment of acute coronary syndromes. The vote, by the nine panel members of the Cardiovascular and Renal Drugs Advisory Committee, was based largely on the premise that the antiplatelet agent represents an advance over existing treatment strategies. "I think there is a compelling need for a drug that has more predictable pharmacokinetics and pharmacodynamics than clopidogrel," said advisory panel member Dr Richard Cannon (National Institutes of Health, Bethesda, MD). "I think the issue of clopidogrel resistance is real and it matters, and this drug is a major advance in that regard." Data on prasugrel were based largely on the pivotal Trial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibition with Prasugrel (TRITON-TIMI 38). That study, first presented by Dr Steven Wiviott (Brigham and Women's Hospital, Boston, MA) at the American Heart Association 2007 Scientific Sessions and reported by heartwire at that time, showed significantly reduced ischemic events with the new drug compared with clopidogrel, but at the expense of an increase in major bleeding in ACS patients scheduled for PCI. "With every new antiplatelet or antithrombotic agent that came along, there's often been a promise of dissociation between benefit and risk," panel chair Dr Marvin Konstam (Tufts University School of Medicine, Boston, MA) said today. "There was some anticipation based on phase 2 data that this might be the case with the dosing regimen prescribed, but we should point out that it didn't work that way. There was incremental benefit, what was clearly a greater antiplatelet effect, but it came with a cost." Earlier this morning, Dr Elliott M Antman (Brigham and Women's Hospital), a TRITON-TIMI-38 investigator, provided a detailed analysis of the risk/benefit trade-off with the antiplatelet agent, saying he believes the drug represents an advance in the treatment of ACS. Many panel members thought the same.