Johnson & Johnson has submitted an NDA for rivaroxaban to the FDA. The drug, an investigational, oral, once-daily anticoagulant for the prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients undergoing hip or knee replacement surgery, was co-developed with Bayer HealthCare AG.
Ortho-McNeil, a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., will market the drug in the U.S., if it's approved. Bayer holds marketing rights in countries outside the U.S.
Venous blood clots, also known as venous thromboembolism (VTE), include DVT — a blood clot in a large vein, usually in the legs — and PE — a blood clot that has traveled to the lungs — both of which are life-threatening but often preventable complications following major orthopedic surgery.
The filing was supported by data from the global RECORD (REgulation of Coagulation in major Orthopedic surgery reducing the Risk of DVT and PE) clinical trial program. The RECORD program involved more than 12,500 patients in four studies and compared rivaroxaban to injected enoxaparin, for the prevention of total VTE in patients undergoing either total knee or hip replacement surgery.