Janssen Research & Development LLC reported results of the EINSTEIN-PE study, demonstrating that the oral anticoagulant XARELTO or rivaroxaban was comparable to today's standard of care in treating patients with acute symptomatic pulmonary embolism or PE and in preventing secondary venous blood clot development, also called as venous thromboembolism or VTE. Further, the study discovered that rivaroxaban had a similar safety profile and significantly lower risk of major bleeding versus the current standard regimen.
The EINSTEIN-PE study compared rivaroxaban to enoxaparin followed by vitamin K antagonist in the treatment of 4,833 patients with acute symptomatic PE for the prevention of recurrent VTE. Patients received treatment for three, six or 12 months. As a result of the study, rivaroxaban showed non-inferiority to standard therapy for the primary endpoint of recurrent symptomatic VTE, a composite of symptomatic deep vein thrombosis or DVT and non-fatal or fatal PE. In addition, Rivaroxaban demonstrated similar results compared to standard of care for the principal safety outcome measuring a composite of major and non-major clinically relevant bleeding events.
Rivaroxaban treatment also resulted in a significant reduction in major bleeding events versus standard therapy. VTE is the collective term for both deep vein thrombosis or DVT and PE. The company intends to file the EINSTEIN studies in a supplemental New Drug Application with the FDA during the second quarter of this year. Janssen Research & Development LLC and Janssen Pharmaceuticals Inc. are part of the Janssen Pharmaceutical Companies of Johnson & Johnson (JNJ).
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