Xarelto approved for treatment of pulmonary embolism and prevention of recurrent deep vein thrombosis and pulmonary embolism in the European Union
European Commission ( EC ) has approved oral anticoagulant Xarelto ( Rivaroxaban ) for the treatment of pulmonary embolism ( PE ) and the prevention of recurrent deep vein thrombosis ( DVT ) and pulmonary embolism in adults.
Until now, the standard therapy has been the dual drug combination of daily injections of a low molecular weight Heparin, together with an oral vitamin K antagonist.
The approval of Rivaroxaban for the treatment of pulmonary embolism and the prevention of recurrent deep vein thrombosis and pulmonary embolism in adults is based on the pivotal, global phase III EINSTEIN-PE study. With 4,833 patients enrolled, EINSTEIN-PE is the largest study ever conducted in the acute treatment of pulmonary embolism.
The study compared the oral single-drug solution of Rivaroxaban 15 mg twice daily for three weeks, followed by 20 mg once daily, with the current dual drug approach of subcutaneous Enoxaparin followed by a oral vitamin K antagonist.
Patients were treated for three, six or 12 months.
Rivaroxaban has demonstrated efficacy comparable to that of the current standard therapy in reducing the primary endpoint of recurrent symptomatic venous thromboembolism, a composite of symptomatic deep vein thrombosis and non-fatal or fatal pulmonary embolism, without the need for laboratory monitoring.
The overall bleeding rates were similar between the treatment groups, but importantly Rivaroxaban was associated with significantly lower rates of major bleeding.
The results from this study were published in the New England Journal of Medicine ( NEJM ).
Rivaroxaban is an oral, once-daily, direct Factor Xa inhibitor.
To date, Xarelto is approved for use in the following venous arterial thromboembolic ( VAT ) indications:
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 in adults;
treatment of pulmonary embolism and prevention of recurrent deep vein thrombosis and pulmonary embolism in adults;
prevention of venous thromboembolism in adult patients undergoing elective hip or knee replacement surgery.
Source: Bayer HealthCare, 2012