Johnson & Johnson Pharmaceutical Research & Development announced on 7 January 2011 that it has submitted a new drug application to the US Food and Drug Administration (FDA) for rivaroxaban, an investigational, oral, once-daily anticoagulant, for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (AF).
The submission is supported by data from the pivotal, global phase 3 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.
Johnson & Johnson also announced that it has submitted its complete response to the FDA seeking approval to use rivaroxaban for the prevention of deep vein thrombosis and pulmonary embolism in patients undergoing total hip or total knee replacement surgery.
Rivaroxaban is a novel oral anticoagulant being evaluated for the prevention and treatment of a broad range of disorders in which blood clotting plays a major role. In clinical studies, the compound has shown no requirement for routine laboratory coagulation monitoring, and limited risk for food and drug interactions. The extensive programme of clinical trials evaluating this compound makes rivaroxaban the most studied oral, direct Factor Xa inhibitor in the world today. By the time of its completion, more than 65,000 patients will have participated in the rivaroxaban clinical development programme.