Effient Approval Shows Mark Of FDA Controls
This article was originally published in The Pink Sheet Daily
Executive SummaryPostmarketing trials offer opportunity to investigate a possible means to control the bleeding caused by prasugrel, but REMS includes messaging aimed at limited off-label use.
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Novel antiplatelet product has suffered from excess bleeding rates in clinical trials and is searching for an appropriate patient population, after initial hopes of being a blockbuster.
U.S. physicians say skepticism over the North American results in the pivotal PLATO study is one of many factors that’s been slowing adoption. Competition with low-cost generics is another.
A study published in the New England Journal of Medicine showed Effient was not superior to Plavix in treating patients who had not undergone revascularization.