FDA Advisory Panel Votes Against Approving Rivaroxaban for Patients With ACS

The U.S. Food and Drug Administration’s (FDA) Cardiovascular and Renal Drugs Advisory Committee has voted unanimously against approving rivaroxaban (XARELTO®) for patients with acute coronary syndromes (ACS) due to a lack of sufficient evidence. The same committee voted against the drug’s expanded use in 2012. While the FDA is not required to adhere to the advisory panel’s recommendation, it often does.

Last year, the FDA determined the risk of bleeding was too great to approve the drug for patients with ACS even though the ATLAS ACS 2 TIMI 51 found that rivaroxaban "significantly reduced the primary efficacy end point of death from cardiovascular causes, myocardial infarction, or stroke" in this patient population. The FDA also rejected rivaroxaban for ACS in June 2012.

Rivaroxaban, an oral anticoagulant that acts by selective direct inhibition of factor Xa (FXa), is FDA-approved to prevent stroke in nonvalvular atrial fibrillation, treat deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and reduce the risk of recurrence of DVT and PE following initial treatment, and prevent DVT after knee or hip replacement surgery.

Keywords: Acute Coronary Syndrome, Advisory Committees, Anticoagulants, Atrial Fibrillation, Factor Xa, Morpholines, Myocardial Infarction, Pulmonary Embolism, Stroke, Thiophenes, United States Food and Drug Administration, Venous Thrombosis

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