Another US loss for Xarelto: FDA rejects stent thrombosis indication
This article was originally published in Scrip
Executive Summary
Johnson & Johnson subsidiary Janssen and its partner Bayer HealthCare acknowledged on 28 June that the FDA is not ready to give its OK to Xarelto (rivaroxaban) as a treatment to reduce the risk of stent thrombosis in patients with acute coronary syndrome (ACS), despite the medicine's US approval in six other indications – even being the most prescribed oral anticoagulant in the nation.