FDA Rejects ACS Indication for Rivaroxaban for the second time.
Janssen Pharmaceuticals, the marketer of the oral factor Xa inhibitor rivaroxaban (Xarelto), announced on March 4 that the FDA has issued a second complete response letter (CRL) regarding the supplemental new drug application submitted for the use of the drug in patients with acute coronary syndrome (ACS). CRLs typically indicate that the FDA would like to see more data.
In response to the first CRL, received in June 2012, Janssen submitted data related to patients who had withdrawn from the ATLAS ACS 2 TIMI 51 trial, a large part of the basis for the drug’s pending approval. The company said it will continue to work with the FDA to address questions about the drug.
Rivaroxaban is currently approved for multiple indications, including the treatment of stroke in patients with nonvalvular atrial fibrillation, and to reduce the risk for deep venous thrombosis or pulmonary embolism in patients undergoing hip or knee replacement surgery.
Read more at theheart.org.