Bayer HealthCare's (BYR.L, BAYRY.PK, BAYZF.PK) oral anticoagulant Xarelto (rivaroxaban) has been recommended for approval by the European Committee for Medicinal Products for Human Use or CHMP for the treatment of pulmonary embolism or PE and the prevention of recurrent deep vein thrombosis or DVT and PE in adults. The decision of the European Commission on the approval is expected before the year-end.
The CHMP recommendation to approve rivaroxaban for the treatment of PE and the prevention of recurrent DVT and PE in adults is based on the important clinical findings from 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 PE. 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 VKA.
Patients were treated for either 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 deep vein thrombosis (DVT) and non-fatal or fatal PE, 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.
EINSTEIN-PE is one of three Phase III studies in the global EINSTEIN program that evaluated the safety and efficacy of rivaroxaban in the treatment of venous thromboembolism in almost 10,000 patients. The other two trials - EINSTEIN-DVT and EINSTEIN-EXT - were published together in the New England Journal of Medicine in December 2010. In December 2011, Xarelto (rivaroxaban) received European Commission approval for the treatment of DVT and the prevention of recurrent DVT and PE following an acute DVT in adults.
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