According to a BioSpace report, rivaroxaban (Xarelto™) has been approved for use in the UK for the following two blood clotting disorders:

• Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (AF) 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.

Rivaroxaban is already licensed in the UK for the prevention of (VTE) in adult patients undergoing elective hip or knee replacement surgery.

The approvals were granted by the European Commission following a close review of the drug's clinical trial data by the European Medicines Agency.

The ROCKET AF study compared once daily rivaroxaban with dose adjusted warfarin in 14,264 patients with non-valvular AF who were at risk for stroke or non-CNS systemic embolism and demonstrated that rivaroxaban was non-inferior to warfarin in prevention of stroke in non valvular AF.

In EINSTEIN, DVT patients with acute DVT taking rivaroxaban 15mg twice daily for 3 weeks followed by 20mg were compared with initial enoxaparin treatment followed by warfarin. The study demonstrated that rivaroxaban was non-inferior to enoxaparin and warfarin in recurrence of symptomatic blood clots in patients with DVT. In both studies, rivaroxaban was reported to be well tolerated.