Xarelto gains US FDA reviewer's support in ACS ahead of cardiac panel
This article was originally published in Scrip
Executive Summary
A US FDA drug reviewer on 21 May recommended approval of Janssen Pharmaceuticals' supplemental new drug application (sNDA) to market its oral anticoagulant Xarelto (rivaroxaban) in combination with aspirin plus a thienopyridine – clopidogrel or ticlopidine – as a therapy to reduce the risk of thrombotic cardiovascular events in patients with acute coronary syndrome (ACS), despite concerns over missing data and bleeding events.