FONT-SIZE Plus   Neg

XARELTO Found As Effective As Standard Treatment In VTE Trial - Quick Facts

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).

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
AT&T announced a definitive agreement to purchase Time Warner in a stock-and-cash transaction valued at $107.50 per share. This purchase price implies a total equity value of $85.4 billion and a total transaction value of $108.7 billion, including Time Warner's net debt. AT&T expects the deal to close before year-end 2017. Chipmaker Qualcomm is reportedly in talks with NXP Semiconductor NV (NXPI) for a possible acquisition, reports said. According to Bloomberg, negotiations are on with a probable price of $110 t $120 per NXP share. The deal would value NXP at around $34.7 billion. Regulators have confirmed the eleventh U.S. fatality linked to Takata Corp.'s defective air bag inflators. The National Highway Traffic Safety Administration or NHTSA said Thursday that a crash fatality in Riverside County, California, was tied to the rupture of a recalled Takata air bag inflator.
comments powered by Disqus
Follow RTT