US FDA drug reviewers advise against approval of J&J-Bayer stroke drug
This article was originally published in Scrip
Executive Summary
US FDA drug reviewers said there was a lack of substantial evidence that Johnson & Johnson's and Bayer Healthcare Pharmaceiticals’ Xarelto (rivaroxaban) would have its desired effect when used to prevent stroke and systemic embolism in patients with nonvalvular atrial fibrillation and insisted there was insufficient information about the drug to determine whether it is safe for that use.