ARTICLE | Clinical News

Xarelto rivaroxaban regulatory update

February 24, 2014 8:00 AM UTC

FDA notified Johnson & Johnson that the REMS for Xarelto rivaroxaban met its goals and is no longer required. Xarelto is approved in the U.S. to prevent deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients undergoing hip or knee replacement surgery, to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (AF), to treat DVT or PE and to reduce the risk of recurrent DVT. The REMS had consisted of a timetable for submission of assessments of the REMS and a communication plan to ensure the benefits of Xarelto outweighed the risks in patients with non-valvular AF, including an increased risk of thrombotic events if Xarelto is prematurely discontinued without introducing an adequate alternative anticoagulant and a potential decreased efficacy of the drug if not taken with the evening meal. ...