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Bleeding Rates In TRA-2P Further Dim Outlook For Merck’s Vorapaxar

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Outcomes study of about 25,000 patients shows novel antiplatelet drug reduces events but also increases major bleeding, including intracranial hemorrhage.

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Large, complex dataset supporting Merck’s vorapaxar NDA invited “slicing and dicing” of the data by the primary reviewers – and made weight-based restrictions a key issue at the late-cycle and advisory committee meetings. But unusual, late-in-the-game reviews by high level FDA officials led to a post-panel U-turn.

FDA Changed Course On Zontivity Because Of Skepticism Of Subgroups At High Levels

Large, complex dataset supporting Merck’s vorapaxar NDA invited “slicing and dicing” of the data by the primary reviewers – and made weight-based restrictions a key issue at the late-cycle and advisory committee meetings. But unusual, late-in-the-game reviews by high level FDA officials led to a post-panel U-turn.

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