Rivaroxaban regulatory update

FDA approved an sNDA from Johnson & Johnson for Xarelto rivaroxaban to treat deep vein thrombosis (DVT) or pulmonary embolism (PE), and to reduce the risk of recurrent DVT and PE. The oral Factor Xa inhibitor is marketed in the U.S. to treat DVT and PE in patients undergoing knee or hip replacement surgery, and to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (AF). In September, J&J submitted a response to an FDA complete response letter for an sNDA for Xarelto to reduce the risk of cardiovascular events in patients with acute coronary syndrome (ACS). The pharma also resubmitted an sNDA to FDA for the product to reduce the risk of stent thrombosis in ACS patients (see BioCentury, Sept. 10). J&J has U.S. rights to rivaroxaban from Bayer. ...