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Janssen Research & Development Submits XARELTO® (rivaroxaban) to U.S. FDA for the Treatment and Prevention of Recurrent Venous Thromboembolism
Date:5/2/2012

RARITAN, N.J., May 2, 2012 /PRNewswire/ -- Janssen Research & Development, LLC, (Janssen), announced today that it has submitted supplemental New Drug Applications (sNDAs) to the U.S. Food and Drug Administration (FDA) seeking approval for the use of XARELTO® (rivaroxaban), an oral anticoagulant, to treat patients with deep vein thrombosis (DVT) or pulmonary embolism (PE) and prevention of recurrent venous thromboembolism (VTE).

These submissions are supported by data from the global EINSTEIN program, which included two Phase 3 studies that evaluated the safety and efficacy of rivaroxaban in the treatment of patients with acute symptomatic DVT or PE and the prevention of recurrent, symptomatic VTE in these patients. The third Phase 3 study evaluated the safety and efficacy of rivaroxaban in the long-term prevention of recurrent symptomatic VTE. In total, these Phase 3 studies included more than 9,400 patients.

DVT is a condition in which blood clots form in one of the large, deep veins, usually in the legs. PE is a serious condition that most commonly occurs when part or all of a DVT dislodges and travels to the heart, where it can partially or completely block a branch of the pulmonary artery. When PE occurs with large clots, multiple clots, or when the patient already has pre-existing heart or lung disease, the event may be fatal.  VTE is the collective term for both DVT and PE. Each year an estimated 900,000 Americans experience an episode of VTE, resulting in an estimated 300,000 annual deaths.

About the EINSTEIN Program
The EINSTEIN program included three Phase 3 studies. The EINSTEIN-PE study was an open-label, randomized, non-inferiority trial. The trial compared oral rivaroxaban – 15 mg twice daily for three weeks, followed by 20 mg once daily – with the current standard of care of enoxaparin followed by a Vitamin K Antagonist (VKA) in patients with acute symptomatic PE with or without
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SOURCE Janssen Research & Development, LLC
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