European Approval for Rivaroxaban for PE/DVT

Shelley Wood


November 20, 2012

The European Commission has given the green light to a new indication for rivaroxaban (Xarelto, Bayer).

Rivaroxaban, which earned approval as a warfarin alternative for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation last year, today got its indication extended to include treatment of pulmonary embolism (PE) and the prevention of recurrent deep vein thrombosis (DVT) and PE in adults.

This follows the positive opinion of the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) last month, as reported by heartwire .

The extended rivaroxaban approval means this agent is the only one of the new oral anticoagulants approved for the DVT/PE indication in Europe. Approval for this use comes from the EINSTEIN clinical trial program.

Rivaroxaban already holds FDA approval for stroke prevention in nonvalvular AF, treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and to reduce the risk of recurrences following initial treatment, and for the prevention of DVT and PE after knee or hip replacement.

The rivaroxaban approval today covers a 15-mg and 20-mg dose. In the EINSTEIN-PE study, patients received rivaroxaban 15 mg twice daily for 3 weeks, followed by 20 mg once daily for 3, 6, or 12 months.