The company is withdrawing this sNDA because it is contingent on a separate sNDA, for rivaroxaban to reduce the risk of secondary cardiovascular events in patients with ACS, which Janssen R&D received a complete response letter from the FDA on 21 June 2012. Data from the ATLAS ACS 2 TIMI 51 trial support both sNDAs.
“We remain confident in the overall study results from the ATLAS ACS 2 TIMI 51 trial, including the observed reduction in stent thrombosis that formed the basis for this separate sNDA,” said Burton. “Our top priority is to work with FDA on our original sNDA for ACS and submit our reply to the complete response letter as soon as possible. We plan to resubmit the sNDA for stent thrombosis at the same time.”
