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

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...