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US panel to review Lilly/Daiichi's prasugrel in February

This article was originally published in Scrip

Executive Summary

The US FDA's cardiovascular and renal drugs advisory panel will meet on February 3rd to review Lilly/Daiichi Sankyo's Effient (prasugrel), further delaying US approval of the novel platelet inhibitor. The NDA was filed in December 2007 and designated for priority review. In June the FDA extended the review period by three months, later allowing the re-set September deadline to pass without action. The panel will be asked to weigh prasugrel's risks and benefits in light of results from the pivotal TRITON-TIMI 38 study, in which the drug provided a 19% reduction in major cardiovascular events compared with Sanofi-Aventis/Bristol-Myers Squibb's Plavix (clopidogrel) in acute coronary syndrome patients undergoing percutaneous coronary intervention, albeit with a 32% increase in serious bleeding. In December the EU's CHMP granted a positive opinion recommending approval of prasugrel (as Efient).

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