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FDA Declines Stent Thrombosis Indication for Rivaroxaban
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The FDA has issued a complete response letter to Jannsen Pharmaceuticals that declines the request of the manufacturer to expand the indication of its factor Xa inhibitor rivaroxaban to include the reduction of stent thrombosis in patients with ACS.
This news comes after the FDA’s decision in March to reject for a second time the company’s supplemental new drug application (NDA) for an ACS indication for rivaroxaban (Xarelto).
Christopher Nessel, MD, vice president and cardiovascular franchise medical leader at Janssen, said in a press release that the company remains confident in the results of the ATLAS ACS 2-TIMI 51 trial and are in ongoing discussions with the FDA regarding this supplemental NDA.
In April, a substudy of the ATLAS ACS2-TIMI 51 trial was published online in the Journal of the American College of Cardiology, and results showed that patients treated with a 2.5 mg twice daily dose of rivaroxaban plus aspirin and a thienopyridine had a lower incidence of definite and probable stent thrombosis compared with aspirin plus a thienopyridine (1.5% vs. 1.9%; HR=0.61; P=.023).
Rivaroxaban is currently the only factor Xa inhibitor FDA approved for six indications, including reducing the risk for stroke and systemic embolism in patients with nonvalvular atrial fibrillation, and for the treatment of deep vein thrombosis or pulmonary embolism and reduction of risk for recurrence after initial treatment.