Johnson & Johnson Pharmaceutical Research & Development, LLC (J&JPRD) has submitted a New Drug Application to US Food and Drug Administration (FDA) for rivaroxaban, 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.
In 2005, J&JPRD entered into an agreement with Bayer HealthCare AG to jointly develop rivaroxaban. If approved by the FDA, Ortho-McNeil, a Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc, will market the drug in the US Bayer HealthCare holds marketing rights in countries outside the US, a Johnson & Johnson press release said.
Venous blood clots, also known as Venous Thrombo Embolism (VTE), include DVT - a blood clot in a large vein, usually in the legs - and PE - a blood clot that has travelled to the lungs - both of which are life-threatening but often preventable complications following major orthopaedic surgery. Annually in the US, more than 9,00,000 people suffer from VTE events, and 3,00,000 individuals die from VTE. Patients undergoing hip or knee replacement surgery are at high risk for VTE because the large veins of the leg that carry blood back to the heart are significantly damaged during these procedures. In fact, venous blood clots occur in up to 40 per cent of patients undergoing major orthopaedic surgery who do not receive preventative care. Each year, approximately 7,00,000 Americans elect to have hip and knee replacement surgeries, and a blood clot is the most common cause of re-hospitalization for this patient group.
The filing was supported by data from the global RECORD (REgulation of Coagulation in major Orthopaedic 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.
Johnson & Johnson Pharmaceutical Research & Development, LLC (J&JPRD) is a wholly-owned subsidiary of Johnson & Johnson, the world's most broadly based producer of health care products.