FDA advisers back J&J-Bayer stroke drug, but call for warfarin transition testing
This article was originally published in Scrip
Executive Summary
Although Johnson & Johnson and its partner Bayer Healthcare Pharmaceuticals won the backing of a US FDA advisory panel in a 9-2 vote, with one abstention, for Xarelto (rivaroxaban) as a therapy to prevent stroke and systemic embolism in patients with non-valvular atrial fibrillation, regulators made it clear that the committee's discussion carried the heavier weight.