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Published on 20 December 2011

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Xarelto® earns UK stroke prevention approval

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The oral anticoagulant Xarelto® (rivaroxaban) has now been granted approval by the European Commission (EC) for use in the United Kingdom across two new indications:

  • The prevention of stroke and non-CNS systemic embolism in adult patients with non-valvular atrial fibrillation (AF) and one or more risk factors for stroke including congestive heart failure, hypertension, age over 75 years, diabetes and prior stroke, at a fixed dose of 20mg once-daily. A 15mg dose has been approved for moderate to severe renal impairment patients, based on subgroup results from the ROCKET AF trial that demonstrated consistent findings with overall ROCKET AF results
  • The treatment of deep vein thrombosis (DVT) and prevention of recurrent DVT and pulmonary embolism (PE) following an acute DVT in adults

 

Xarelto will be made available at a retail list price of £2.10 per tablet across both indications. This provides the NHS with an effective and simple to use non Vitamin K antagonist (VKA) oral anticoagulant in the UK.

“Antithrombotic medicine is a fast-evolving area in which we are continually improving our understanding of how to combat blood clots,” said Professor Keith Fox, Professor of Cardiology at the University of Edinburgh.

“Treatments which act at a key point in the blood-clotting process are now emerging as an important therapy option in both short and long-term clinical settings, and have the potential to help re-shape clinical practice.”

Rivaroxaban is already available in the UK to help prevent VTE in patients undergoing elective total hip or knee replacement surgery, and has treated over one million patients worldwide in this indication with over 100,000 patients in the UK alone.

Bayer Healthcare


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