Xareto (J&J/Bayer) is FDA filed for Acute Coronary Syndrome

Johnson & Johnson and Bayer HealthCare submitted a supplemental new drug application to the FDA on 29 December seeking approval to market the oral anticoagulant Xarelto (rivaroxaban) as a therapy to reduce the risk of thrombotic events in patients with Acute Coronary Syndrome. The submission includes data from the pivotal Phase III ATLAS ACS 2 TIMI 51 trial, which showed that Xarelto in combination with standard therapy reduced cardiovascular deaths by more than 30% in Acute Coronary Syndrome patients.