Xarelto sNDA gets FDA Priority Review for VTE

The Janssen Research & Development LLC unit of Johnson & Johnson (NYSE:JNJ) said FDA accepted and granted Priority Review to an sNDA for a once-daily 10 mg dose of Xarelto rivaroxaban (BAY 59-7939) to reduce the risk of recurrent venous thromboembolism (VTE) after ≥6 months of standard anticoagulant therapy. Its PDUFA date is Oct. 28.

The direct Factor Xa inhibitor is approved in the U.S. to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (AF); to treat deep vein thrombosis (DVT) and pulmonary embolism (PE) and reduce the risk of recurrent DVT and PE; and prophylaxis of DVT which may lead to PE in patients undergoing hip or knee replacement surgery...