Bayer (BYR.L,BAYRY.PK,BAYZF.PK) said its cooperation partner, Janssen Research & Development, LLC has submitted supplemental New Drug Applications to the U.S. Food and Drug Administration, or FDA, seeking approval for the use of the oral anticoagulant Xarelto (rivaroxaban) to treat patients with deep vein thrombosis, or DVT, or pulmonary embolism, or PE, and to prevent recurrent venous thromboembolism, or VTE.
The submissions are supported by data from the global EINSTEIN program, which included almost 10,000 patients. The three Phase III studies evaluated the safety and efficacy of rivaroxaban in the treatment of DVT and PE and the prevention of recurrent VTE.
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