Xarelto's Comparative Efficacy To Warfarin, Pradaxa Will Be Focus At FDA Panel Review
This article was originally published in The Pink Sheet Daily
FDA will ask its Cardiovascular and Renal Drugs Advisory Committee whether Bayer/Johnson & Johnson's anticoagulant rivaroxaban must be shown to be "as effective" as warfarin and/or Boehringer Ingelheim's dabigatran at preventing stroke in atrial fibrillation patients.
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Structured benefit/risk framework requires consideration of current treatment options, agency says in asking its cardio-renal advisory committee to consider the existence of three other novel anticoagulants when weighing the poor efficacy seen with Daiichi’s Factor Xa inhibitor in a large patient subgroup.
With an unrestricted label and once-daily dosing, rivaroxaban will do battle with Boehringer-Ingelheim's dabigatran, which is dosed twice a day but can claim superior efficacy to warfarin in the atrial fibrillation population.