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Effient Labeling Could Give Edge Against Plavix Through Pharmacogenetics

Executive Summary

FDA cleared Lilly/Daiichi Sankyo's oral platelet inhibitor Effient (prasugrel) at both 5 mg and 10 mg doses on July 10, with a carefully constructed label that reflects the level of regulatory consideration - and negotiation - that went into the approval

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FDA's approval of Lilly/Daiichi Sankyo's antiplatelet agent Effient (prasugrel) reflects the review team’s willingness to look past the increased risk of bleeding – a dramatic and viscerally alarming adverse event, though understandable due to the medical setting – to see the less immediately apparent benefit of a reduction in a type of cardiac event that includes so-called "silent MIs" that have no visible clinical presentation.

"Silent" MIs Outweigh "Scary" Bleeds, FDA Concludes In Effient Review

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