Janssen withdraws one Xarelto sNDA, gets priority review for another
This article was originally published in Scrip
Executive Summary
Janssen Research & Development's disclosed on 9 July that it is withdrawing its supplemental new drug application (sNDA) for its anticoagulant Xarelto (rivaroxaban) as a therapy to reduce the risk of stent thrombosis in patients with acute coronary syndrome (ACS) – an application contingent on a separate filing for the drug in another ACS indication, which was rejected last month by the US FDA.