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

 
• By Bridget Silverman

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 is not obligated to follow the recommendations of its advisory committees, but rarely does it change course as sharply as it did in approving Merck & Co. Inc.’s Zontivity for secondary prevention of atherothrombotic events. Underlying the turn is a streak of skepticism about the value of subgroup analyses in the upper levels of the Office of Drug Evaluation I, FDA review documents show.

Restriction of Zontivity (vorapaxar) to patients who weigh over 60 kg was a key issue at the late-cycle review meeting and subsequent advisory committee, based on concerns expressed by the...

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