FDA Again Denies Rivaroxaban ACS Indication

February 14, 2014

BETHESDA, MD – The US Food and Drug Administration (FDA) has turned away a proposed expanded indication for rivaroxaban (Xarelto, Bayer/Janssen Pharmaceuticals) and rejected the new oral anticoagulant as a treatment for patients with acute coronary syndrome (ACS)[1].

The FDA issued a complete response letter (CRL) to the manufacturer today. This is the third time the agency has denied the supplemental new drug application (sNDA) for the rivaroxaban ACS indication, but the decision is hardly surprising given last month's FDA advisory committee meeting.

In January, the Cardiovascular and Renal Drugs Advisory Committee voted almost unanimously against approving rivaroxaban as a treatment in ACS patients, with 10 panel members voting against recommending approval and one panel member abstaining from the vote.

In addition to denying the sNDA for rivaroxaban in ACS to reduce the risk of MI, stroke, or death, the FDA also denied an expanded indication for rivaroxaban in ACS patients to reduce the risk of stent thrombosis. The company had proposed using rivaroxaban in combination with standard antiplatelet therapy.

Bayer/Janssen Pharmaceuticals had sought the expanded indication for rivaroxaban based on data from the ATLAS-ACS TIMI-51 trial. In a statement issued today, the companies say they will evaluate the contents of the CRL and determine the appropriate next steps. They say they remain committed to providing patients with ACS additional protection against adverse thrombotic cardiovascular events.

Rivaroxaban remains approved to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. It is also approved to prevent deep vein thrombosis (DVT) and pulmonary embolism (PE) following hip- or knee-replacement surgery and to treat and reduce the risk for recurrent DVT and PE.

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