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FDA casts doubt over rivaroxaban for ACS


Bayer HealthCare announced today that the U.S. Food and Drug Administration’s (FDA’s) Cardiovascular and Renal Drugs Advisory Committee voted against the approval of the oral anticoagulant Xarelto® (rivaroxaban) 2.5 mg BID in combination with standard antiplatelet therapy to reduce the risk of secondary cardiovascular events in patients with acute coronary syndrome (ACS).

“We appreciate the thoroughness of the Committee and, together with our cooperation partner Janssen Research & Development, LLC, we will ensure that the questions raised today are addressed so the FDA may finalise their review,” said Dr. Kemal Malik, Member of the Bayer HealthCare Executive Committee and Head of Global Development.

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 haemorrhagic 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, global Phase III ATLAS ACS 2-TIMI 51 study, which compared oral rivaroxaban dosed twice daily in addition to standard antiplatelet therapy — low-dose aspirin with or without a thienopyridine such as clopidogrel — with standard antiplatelet therapy alone in preventing secondary cardiovascular events (cardiovascular death, myocardial infarction or stroke) in patients with ACS.

Results from the ATLAS ACS 2-TIMI 51 study, presented at the 2011 American Heart Association Scientific Sessions and published simultaneously in the New England Journal of Medicine (10.1056/NEJMoa1112277), showed that the combination of oral rivaroxaban 2.5 mg BID with standard antiplatelet therapy significantly reduced the composite primary efficacy endpoint of cardiovascular death, myocardial infarction or stroke in patients after a recent ACS compared to those receiving standard antiplatelet therapy alone.


In addition, rivaroxaban 2.5 mg BID in combination with standard therapy significantly reduced the rate of cardiovascular mortality by 34% and the incidence of all-cause mortality by 32% over standard therapy alone, with the benefit established early and maintained through two years. 

In patients receiving 2.5 mg BID of rivaroxaban in combination with standard antiplatelet therapy, the rate of TIMI major bleeding events not associated with coronary artery bypass graft (CABG) surgery were low overall, yet increased versus those treated with standard therapy alone. Importantly, these differences were not associated with an increase in the risk of fatal bleeding or fatal intracranial haemorrhage (ICH).

The FDA assigned a Priority Review designation to the supplemental New Drug Application (sNDA) filed by Bayer’s cooperation partner Janssen Research & Development, LLC 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 is not bound to follow them. 
If approved by the FDA, Janssen Pharmaceuticals, Inc. (a Johnson & Johnson Company) will commercialise rivaroxaban for this additional indication in the U.S. 

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