The submission for stroke prevention in patients with AF is supported by data from the pivotal, global Phase III ROCKET AF trial that was presented at the American Heart Association (AHA) Congress in November 2010.
ROCKET AF, EINSTEIN-DVT and EINSTEIN-Extension are part of the global development program that has demonstrated the benefit of rivaroxaban in the seven Phase III studies completed to date.
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. The U.S. Bayer HealthCare sales force will support the Ortho-McNeil sales force by detailing rivaroxaban in designated hospital accounts. Bayer HealthCare is exclusively responsible for the marketing of rivaroxaban in countries outside the U.S.