Bayer's XareltoÃ‚® (rivaroxaban) Becomes First Fixed Dose Once-Daily Anticoagulant Tablet Approved in the UK for Stroke Prevention in non-valvular Atrial Fibrillation; and the ...
NEWBURY, England, December 19, 2011 /PRNewswire/ --
- First once-daily, fixed-dose preventative treatment for UK patients with non-valvular atrial fibrillation (an irregular heartbeat) at risk of the devastating consequences of stroke
- Xarelto offers a convenient, cost-effective, single drug solution for the treatment of deep vein thrombosis (DVT) without the need for regular injections
- Xarelto is now approved in the UK for the prevention and treatment of three blood clotting conditions, offering an effective therapy without the need for regular blood monitoring
Bayer HealthCare's oral anticoagulant tablet Xarelto® (rivaroxaban) has been approved for use in the United Kingdom in two important blood-clotting disorders:
- Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (AF), often referred to as an irregular heartbeat, who have one or more risk factors
- Treatment of deep vein thrombosis (DVT) and prevention of subsequent DVTs and pulmonary embolism (PE) following an acute DVT in adult patients
The approvals were granted this week by the European Commission following a close review of the drug's clinical trial data by the European Medicines Agency (EMA). Rivaroxaban is already licensed for the prevention of venous blood clots in patients undergoing hip or knee replacement surgery and has treated over 1 million patients worldwide in this indication, including over 100,000 patients in the UK alone.
"The consequences of blood clots can be overwhelming and their prevention and treatment should rightly be considered a health priority," said Trudie Lobban MBE, Chief Executive and Founder of the Atrial Fibrillation Association. "Thrombosis represents a massive burden on patients and the UK health system. Warfarin eligible A