Bayer’s Rivaroxaban Submitted for Marketing Authorisation in Stroke Prevention in Patients with Atrial Fibrillation in the US

Berlin, Germany,  Bayer’s cooperation partner Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) has submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for the oral anticoagulant rivaroxaban for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (AF).

The submission is based on positive results from the pivotal, global Phase III ROCKET AF (Rivaroxaban Once daily oral direct Factor Xa inhibition Compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation) trial in more than 14,000 patients that was presented at the American Heart Association (AHA) Congress in November 2010.

If approved by the FDA, Ortho-McNeil, a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. (a Johnson & Johnson Company), will commercialize rivaroxaban in the U.S. Bayer HealthCare is exclusively responsible for the marketing of rivaroxaban in countries outside the U.S.

Source: Bayer (For use outside the U.S. only)