FDA Green-Lights Janssen's Anticoagulant for Reducing Stroke/Embolism in Nonvalvular AF Patients

FDA approved Janssen Pharmaceuticals’ Xarelto® (rivaroxaban) for use in the reducing the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. The drug was given the agency’s nod earlier this year for use in the prophylaxis of deep vein thrombosis in people undergoing knee or hip replacement surgery. Janssen claims Xarelto is the only oral anticoagulant approved in the U.S. that enables once-daily dosing without the need for routine blood monitoring.

Clearance of Xarelto for the atrial fibrillation indication was based on data from the Phase III Rocket AF study, which was published in NEJM in September. The 14,264-patient study was designed to determine whether rivaroxaban was noninferior to warfarin for the primary end point of stroke or systemic embolism. In the primary data analysis, the primary end point occurred in 188 patients in the rivaroxaban group (1.7% per year) and in 241 in the warfarin group (2.2% per year). In the intention-to-treat analysis the primary end point occurred in 269 patients in the rivaroxaban group (2.1% per year) and in 306 patients in the warfarin group (2.4% per year).

FDA has requested that use of Xarelto is associated with a risk evalaution and mitigation strategy (REMS) to highlight the risks of increased thrombotic events, including stroke, if Xarelto is discontinued without introduction of an adequate alternative anticoagulant, and the decreased efficacy of the drug if not taken with an evening meal.

Johnson & Johnson Pharmaceutical Research and Development, Janssen’s research and development affiliate, is developing rivaroxabain in collaboration with Bayer HealthCare. Janssen holds U.S. marketing rights to the drug, and will be supported by the Bayer Healthcare U.S. sales force. The firms are in addition developing rivaroxaban for a range of disorders characterized by blood clotting.