Xarelto approved in the European Union for the prevention of stroke in patients with atrial fibrillation and in the treatment of deep vein thrombosis
Oral anticoagulant Xarelto ( Rivaroxaban ) has been approved by the European Commission ( EU ) for use in two new indications, making it the only new oral anticoagulant approved in three indications across all 27 EU member states: prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors; treatment of deep vein thrombosis and prevention of recurrent deep vein thrombosis and pulmonary embolism following an acute deep vein thrombosis in adults; the prevention of deep vein thrombosis in adult patients undergoing elective hip or knee replacement surgery.
The approval of Rivaroxaban for the prevention of atrial fibrillation-related stroke is based on the important clinical benefits demonstrated in ROCKET AF, a rigorous, double-blind global Phase III study that compared once-daily Rivaroxaban with Warfarin ( Coumadin ) in more than 14,000 patients.
The results from the ROCKET AF trial were published in the New England Journal of Medicine ( NEJM ) in August 2011.
The approval of Rivaroxaban for the treatment of deep vein thrombosis and the prevention of recurrent deep vein thrombosis and pulmonary embolism following an acute deep vein thrombosis, follows submission of data from the Phase III EINSTEIN-DVT study, as well as data from the Phase III EINSTEIN-Extension study.
Both EINSTEIN-DVT and EINSTEIN-Extension were published in the NEJM in December 2010.
Rivaroxaban is an oral anticoagulant that was discovered in Bayer HealthCares Wuppertal laboratories in Germany. It has a rapid onset of action with a predictable dose response and high bioavailability, no requirement for routine coagulation monitoring or regular renal monitoring, as well as a limited potential for food and drug interactions.
The extensive clinical trial program supporting Rivaroxaban makes it the most studied and widely published oral, direct factor Xa inhibitor. The studies, reported and ongoing, involve over 75,000 patients for the prevention and treatment of venous and arterial thromboembolic disorders across a broad range of acute and chronic conditions, including stroke prevention in patients with atrial fibrillation, deep vein thrombosis treatment and the prevention of recurrent deep vein thrombosis or pulmonary embolism, and the secondary prevention of acute coronary syndrome.
Source: Bayer HealthCare, 2011
Link: Xapedia - Medical Encyclopedia