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Rivaroxaban recommended for EU approval

Oral anticoagulant rivaroxaban (Xarelto®, Bayer HealthCare) has been recommended by the European Committee for Medicinal Products for Human Use (CHMP) for the treatment of deep vein thrombosis (DVT) and prevention of recurrent DVT and pulmonary embolism (PE) following an acute DVT in adults. It is also recommended for the prevention of stroke and non central nervous system (CNS) systemic embolism in adult patients with non-valvular atrial fibrillation (AF).

“The decision to recommend rivaroxaban for these new indications underscores the positive risk benefit profile seen in trials testing rivaroxaban against the current standard of care to prevent blood clots in patients with non-valvular AF and DVT,” said Professor Keith Fox, Professor of Cardiology at the University of Edinburgh. “This news is important for patients and their physicians because there is a clear need for effective therapy options which are not restricted by the limitations of current treatments”.

Approval by the Committee in these new indications is expected to follow in the fourth quarter of 2011, meaning rivaroxaban will be authorised for use in all 27 European Union (EU) member states, including the UK.

The positive recommendation for rivaroxaban in the treatment of DVT and the prevention of recurrent DVT and PE following an acute DVT, follows submission of data from the landmark Phase III EINSTEIN-DVT study presented at the European Society of Cardiology (ESC) Congress in August 2010, as well as data from the Phase III EINSTEIN-Extension study, presented in December 2009 at the 51st Annual Meeting of the American Society of Hematology (ASH). Both EINSTEIN-DVT and EINSTEIN-Extension were published in the New England Journal of Medicine in December 2010.

The CHMP recommendation to approve rivaroxaban for the prevention of stroke and non CNS systemic embolism in patients with non-valvular AF is based on the important clinical benefits demonstrated in ROCKET AF, a double-blind global Phase III study that compared once-daily rivaroxaban with warfarin in more than 14,000 patients. The results from the ROCKET AF trial were presented at the American Heart Association (AHA) Congress in November 2010 and published in the New England Journal of Medicine in August 2011.1


1 ROCKET AF Study Investigators. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation, The New England Journal of Medicine, 2011, published online at (10 August 2011).

Published on: September 28, 2011

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  • ArrhythmiaAlliance
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  • Anticoagulation Europe
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