The new drug application (NDA) seeks approval for the use of rivaroxaban in the prevention of deep vein thrombosis and pulmonary embolism in patients undergoing hip or knee replacement surgery.
Rivaroxaban was invented in Bayer’s Wuppertal laboratories and is being jointly developed by Bayer HealthCare, and Johnson & Johnson Pharmaceutical Research & Development. Once marketing authorization has been granted in the US, rivaroxaban will be commercialized by Ortho-McNeil, a division of Ortho-McNeil-Janssen Pharmaceuticals.
Rivaroxaban is said to be the first oral anticoagulant to demonstrate superior efficacy over the US approved twice-daily injectable regimen of enoxaparin, with a similar safety profile and no significant increase in major bleeding. Upon FDA approval, rivaroxaban is expected to become the first novel oral anticoagulant introduced in the US market for more than 50 years.