The European Commission has approved the oral anticoagulant rivaroxaban for the treatment of pulmonary embolism (PE) and the prevention of recurrent deep vein thrombosis (DVT) and PE in adults.
Rivaroxaban (Xarelto) is the only oral anticoagulant approved for these indications in the EU, according to Bayer HealthCare. Rivaroxaban was discovered by Berlin-based Bayer and is being jointly developed with Janssen.
On Oct. 18, the Committee for Medicinal Products for Human Use adopted a positive opinion for rivaroxaban 15 and 20 mg strengths. The oral direct factor Xa inhibitor already was approved in Europe for the prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (AF) with one or more risk factors; for treatment of DVT; and for the prevention of venous thromboembolism in adult patients undergoing elective hip or knee replacement surgery.
The approval of rivaroxaban for these indications was based on clinical findings from the pivotal, global Phase III EINSTEIN-PE study. The study enrolled 4,833 patients enrolled to compare 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 vitamin K antogonist. Patients were treated for three, six or 12 months.
Rivaroxaban demonstrated efficacy comparable to that of the current standard therapy in reducing the primary endpoint of recurrent symptomatic VTE, a composite of symptomatic DVT and nonfatal or fatal PE, without the need for laboratory monitoring. The overall bleeding rates were similar between the treatment groups, but rivaroxaban was associated with significantly lower rates of major bleeding.
In the U.S., the FDA expanded the approved use of rivaroxaban Nov. 2 to include treating DVT or PE and to reduce the risk of recurrent DVT and PE following initial treatment. It was already FDA-approved to reduce the risk of DVTs and PEs from occurring after knee or hip replacement surgery, and to reduce the risk of stroke in people who have nonvalvular AF.