FDA Does Not Approve Expanded Indication for Xarelto to Reduce the Risk of Stent Thrombosis in ACS Patients

June 28, 2013—Janssen Research & Development, LLC (Janssen R&D, Raritan, NJ) announced that the US Food and Drug Administration (FDA) has issued a complete response letter for the supplemental New Drug Application (sNDA) for Xarelto (rivaroxaban) to reduce the risk of stent thrombosis in patients with acute coronary syndromes (ACS). The FDA did not approve the expanded indication for Xarelto at this time. The company stated that it remains confident in the data supporting Xarelto for this indication and will continue to work with the FDA regarding the application.

The company advised that this sNDA is based on results from the 15,526-patient, phase-3, pivotal ATLAS ACS 2 TIMI 51 clinical trial of Xarelto, which were presented at the American Heart Association's annual scientific sessions in November 2011 and published by Jessica L. Mega, MD, et al in The New England Journal of Medicine (2012;366:9–19). Data from the ATLAS ACS 2 TIMI 51 trial also support the separate sNDA for Xarelto to reduce the risk of cardiovascular events in patients with ACS, for which Janssen received a second complete response letter on March 4, 2013, the company stated.

Xarelto is an oral anticoagulant that targets factor Xa, a key trigger of thrombin generation. It is being jointly developed by Janssen R&D and Bayer HealthCare (Leverkusen, Germany). In the United States, Janssen Pharmaceuticals, Inc. (Titusville, NJ) holds the marketing rights for Xarelto. Janssen R&D and Janssen Pharmaceuticals are part of the Janssen Pharmaceutical Companies of Johnson & Johnson (New Brunswick, NJ).

On November 2, 2012, Janssen announced that the FDA approved Xarelto for the treatment of deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and to reduce the risk of DVT and PE recurrence following the initial treatment. Xarelto is approved to treat DVT and PE without the need for injections or routine blood monitoring; it was approved for these three new indications on a priority review timeline of 6 months.

On May 24, Bayer announced that Xarelto had been approved in Europe for the prevention of atherothrombotic events (cardiovascular death, myocardial infarction, or stroke) after ACS in adult patients with elevated cardiac biomarkers at a dose of 2.5 mg twice daily in combination with standard antiplatelet therapy.