RARITAN, N.J. -- Janssen Research & Development, LLC announced today that the U.S. Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee has voted against the approval of XARELTO® (rivaroxaban), an oral anticoagulant, to reduce the risk of secondary cardiovascular events in patients with Acute Coronary Syndrome (ACS) in combination with standard antiplatelet therapy.

"We appreciate the thoroughness of the committee's review, and will ensure the questions raised today are addressed with the FDA," said Paul Burton, M.D., Ph.D., Vice President, Cardiovascular Franchise Medical Leader at Janssen.

XARELTO® is approved in the U.S. to reduce the risk of blood clots in the legs and lungs of people who have just had knee or hip replacement surgery, and to reduce the risk of both hemorrhagic and thrombotic strokes as well as other blood clots in people with atrial fibrillation not caused by a heart valve problem.

Data presented at today's advisory committee meeting included results from the pivotal Phase 3 ATLAS ACS 2 TIMI 51 (Anti-Xa Therapy to Lower cardiovascular events in Addition to aspirin with/without thienopyridine therapy in Subjects with Acute Coronary Syndrome) clinical trial which compared rivaroxaban dosed twice daily (BID) in addition to standard therapy — low-dose aspirin with or without a thienopyridine such as clopidogrel — with standard therapy alone in the composite primary efficacy endpoint of cardiovascular-related deaths, heart attacks or strokes in patients with ACS.

Results from the ATLAS ACS 2 TIMI 51 study showed that rivaroxaban, given in combination with standard antiplatelet therapy was superior to standard therapy alone in preventing secondary cardiovascular events in patients with ACS. In patients receiving rivaroxaban and standard therapy, rates of TIMI major bleeding events not associated with coronary artery bypass graft (CABG) surgery were low overall, yet statistically significantly increased versus those treated with standard therapy plus a placebo. Importantly, these differences were not associated with an excess risk of fatal bleeding.

The FDA assigned a Priority Review designation to the supplemental New Drug Application (sNDA) filed on December 29, 2011 for rivaroxaban in patients with ACS. Recommendations from the advisory committee will be considered by the FDA in its review of the sNDA for rivaroxaban in this indication, but the FDA are not bound to follow them. If approved by the FDA, Janssen Pharmaceuticals, Inc. will commercialize rivaroxaban for this additional indication in the U.S.

Source: Janssen Research & Development, LLC