FDA refuses rivaroxaban stent-thrombosis indication for now

Raritan, NJ - The FDA has given a complete response letter (CRL) to one of the companies behind rivaroxaban (Xarelto, Bayer Pharma/Janssen Pharmaceuticals) indicating that it won"t, for now, approve the oral factor Xa inhibitor for prevention of stent thrombosis in patients with acute coronary syndromes [1]. 

As noted in a statement today from Janssen, approval for that indication had been sought in a supplemental new drug application (sNDA) based largely on the ATLAS ACS 2 TIMI 51 trial. The CRL, which signals that the FDA wants to see additional data before it will further consider the sNDA, follows others that it sent the companies regarding approval of rivaroxaban for patients with ACS, as reported by heartwire. The drug is already approved for ACS secondary prevention in Europe. 

"We remain confident in the results of the ATLAS ACS 2 TIMI 51 trial and are in ongoing discussions with the FDA regarding this sNDA," said a Janssen official in the company"s press release on the stent-thrombosis CRL.

The agency has already approved rivaroxaban, an oral factor Xa inhibitor, for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and for preventing recurrences, for reducing the risk of DVT and PE after knee- or hip-replacement surgery, and for cutting the risk of stroke in nonvalvular atrial fibrillation.