EU backs Bayer's Xarelto for stroke prevention

20 December 2011

The European Commission has approved two new indications for German drug major Bayer HealthCare’s (BAY: DE) Xarelto (rivaroxaban), making it the only new oral anticoagulant approved in three indications across all 27 European Union member states for: • prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (AF) with one or more risk factors;• treatment of deep vein thrombosis (DVT) and prevention of recurrent DVT and pulmonary embolism (PE) following an acute DVT in adults; and • the prevention of VTE in adult patients undergoing elective hip or knee replacement surgery. The move follows a European Medicines Agency advisory panel recommendation in the fall (The Pharma Letter September 26).

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