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Bayer Submits Application For EU Marketing Authorization For Xarelto

4/12/2012 2:59 AM ET

Bayer HealthCare, a subgroup of Bayer AG (BYR.L,BAYRY.PK,BAYZF.PK), said it has submitted an application for marketing authorization to the European Medicines Agency for the oral anticoagulant Xarelto (rivaroxaban) for the treatment of pulmonary embolism, or PE, and the prevention of recurrent deep vein thrombosis and PE in adults.

The submission is supported by data from the pivotal, global Phase III EINSTEIN-PE study. The EINSTEIN-PE study compared the oral single-drug approach of rivaroxaban 15 mg twice daily for three weeks followed by 20 mg once daily with the current standard of care, subcutaneous enoxaparin followed by a VKA.

According to the company, Rivaroxaban demonstrated efficacy comparable to that of the current standard therapy in reducing the primary endpoint of recurrent symptomatic Venous Thromboembolism, or VTE, a composite of symptomatic deep vein thrombosis and non-fatal or fatal PE. The overall bleeding rates were similar between the treatment groups, but importantly rivaroxaban was associated with significantly lower rates of major bleeding.

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by RTT Staff Writer

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