Firms say they will work with agency to address complete response letter.
Partners Janssen Research & Development and Bayer HealthCare failed to get FDA approval to market the anticoagulant Xarelto® (rivaroxaban) for reducing the risk of secondary cardiovascular events among patients with acute coronary syndrome (ACS).The firms have received a complete response letter to the supplemental NDA, which was submitted in December 2011, and say they will work with the agency to address questions.
The sNDA for Xarelto included data from the Phase III Atlas ACS 2 TIMI 51 trial, which evaluated the use of either rivaroxaban or placebo in addition to standard antiplatelet therapy (low-dose aspirin with or without a thienopyridine) in 15,526 patients with ACS. The data, reported in November 2011, showed that rivaroxaban plus standard therapy reduced the risk of cardiovascular events by 16% over and above that of placebo plus standard therapy. A twice-daily 2.5 mg dose of rivaroxaban reduced the rates of death from cardiovascular causes by 34% in comparison with placebo plus standard therapy (2.7% vs. 4.1%), and reduced the risk of death from any cause by 32% (2.9% vs. 4.5%).
Originally discovered by Bayer, Xarelto is being jointly developed by Janssen and Bayer HealthCare. Janssen holds marketing rights to the drug in the U.S., and Bayer holds rights to non-U.S. territories. Rivaroxaban is approved in more than 120 countries worldwide for indications including the reduction of DVT in patients having undergone knee or hip replacement surgery, and for reducing the risk of hemorrhagic and thrombotic stroke in patients with nonvalvular atrial fibrillation.