Rivaroxaban regulatory update

Bayer said the European Commission approved a label expansion for 2.5 mg twice-daily Xarelto rivaroxaban to include the prevention of atherothrombotic events in combination with standard antiplatelet therapy after acute coronary syndrome (ACS) in adults with elevated cardiac biomarkers. EMA's CHMP recommended the label expansion in March (see BioCentury, March 25).

Xarelto is approved in Europe to treat pulmonary embolism (PE) and deep vein thrombosis (DVT). It is also approved to prevent venous thromboembolism (VTE) in patients undergoing hip or knee replacement surgery and to prevent stroke and systemic embolism in patients with non-valvular atrial fibrillation (AF) and recurrent DVT and PE following an acute DVT. ...