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Published on 10 January 2011

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Bayer submits Rivaroxaban to EMA

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NEWBURY, England/PRNewswire/ — Bayer has submitted an application for marketing authorisation to the European Medicines Agency (EMA) for the oral anticoagulant rivaroxaban in stroke prevention in patients with non-valvular atrial fibrillation, as well as for the treatment of deep vein thrombosis (DVT) and prevention of recurrent DVT and pulmonary embolism (PE).

Rivaroxaban is an oral direct Factor Xa inhibitor, and is being jointly developed by Bayer HealthCare and Johnson & Johnson Pharmaceutical Research & Development, L.L.C (J&JPRD).

The submission for stroke prevention in patients with non-valvular AF is supported by data from the pivotal, global Phase III ROCKET AF trial that was presented at the American Heart Association (AHA) Congress in November 2010.

Submission for the treatment of DVT, and prevention of recurrent DVT and PE, is based on data from the Phase III EINSTEIN-DVT trial that was presented at the European Society of Cardiology (ESC) Congress in August 2010, and data from the Phase III EINSTEIN-Extension trial that was presented in December 2009 at the 51st Annual Meeting of the American Society of Haematology (ASH).

The EINSTEIN-DVT and EINSTEIN-Extension data have recently been published in the New England Journal of Medicine (NEJM).



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