Xarelto reccommended in Europe for DVT, Stroke and AF - 26-Sep-2011

Bayer HealthCare’s oral anticoagulant Xarelto (rivaroxaban) has been recommended for approval by the European Committee for Medicinal Products for Human Use (CHMP) for both the prevention of Stroke and systemic embolism in adults with non-valvular Atrial Fibrillation (AF), as well as for the treatment of Deep Vein Thrombosis (DVT) and prevention of recurrent DVT and Pulmonary Embolism (PE) following an acute DVT in adults. The decision of the European Commission is expected in the fourth quarter 2011. The recommendation to approve Xarelto for stroke prevention in Atrial Fibrillation is based on clinical benefits demonstrated in ROCKET AF study. The recommendation for the treatment of DVT and the prevention of recurrent DVT and PE following an acute DVT, follows data from the Phase III EINSTEIN-DVT and EINSTEIN-extension studies.