The antiplatelet agent Plavix (Clopidogrel Bisulfate; BMS/Sanofi Aventis) is the second best selling drug on the market, with sales nearing $8 billion in 2007. Plavix will go generic in 2011 and a much more potent antiplatelet drug called prasugrel (Lilly/Daiichi Sankyo) may soon take its place, or at least that’s what the developers hope to happen. Prasugrel was tested against Plavix recently in a cleverly-designed and somewhat controversial trial called TRITON-TIMI 38. In this trial, prasugrel was shown to be about 3% better than Plavix in preventing the combined primary endpoint of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke in patients with a recent heart attack and scheduled catheterization. Unfortunately prasugrel also increased the risk of major and fatal bleeding in patients, especially the elderly and those with a history of stroke. In TRITON-TIMI 38, for every one major fatal heart attack prevented by prasugrel, one person died from a fatal bleeding event.
Because of the increased efficacy of prasugrel over Plavix, the FDA granted it priority review back in February of this year, promising to announce its decision within six months. The FDA is now delaying its decision and asking for more data and 3 more months to complete its analysis. The bottom line, however, remains that for every one person that we save from a fatal heart attack, one dies from a fatal bleed with prasugrel, giving it a net effect of zero in saving lives and reducing mortality. Now the question becomes if it’s worth spending millions on prasugrel to get such a margin of net real life mortality benefit.
More info: TRITON, FDA Priority Review, FDA Delay
