The Xarelto Trials That Might Have Been
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Johnson & Johnson/Bayer’s Xarelto (rivaroxaban) was cleared for stroke prevention in atrial fibrillation patients unencumbered by new post-marketing studies – but not for lack of suggestions. FDA reviewers had urged further studies on topics ranging from alternate dosing regimens and reversal of drug activity to transitioning to warfarin.