FDA Approves Oral Anticoagulant Rivaroxaban for DVT Prevention at Surgery

Xarelto Gains FDA Approval for DVT Prevention at Surgery

July 01, 2011

July 1, 2011 (Raritan, NJ) — The once-daily oral anticoagulant rivaroxaban (Xarelto, Bayer/Johnson & Johnson) has been approved by the US Food and Drug Administration for prevention of deep venous thrombosis (DVT) in the setting of knee- or hip-replacement surgery, Janssen Pharmaceuticals--which holds the drug's US marketing rights--announced today [1].

Rivaroxaban, a factor Xa inhibitor, joins the direct thrombin inhibitor dabigatran etexilate (Pradaxa, Boehringer Ingelheim) on the US market as the leading edge of what is expected to be a wave of oral anticoagulants aimed at replacing warfarin, one of cardiology's oldest drugs still in wide use. The newly approved drug, Jannsen notes, has already been available in more than 80 countries.

The indication for rivaroxaban in its new labeling is based entirely on its performance in the three RECORD trials, in which it prevented venous thromboembolism in the orthopedic surgical setting significantly better than enoxaparin (Lovenox, Sanofi-Aventis), with no increased bleeding risk.

An FDA advisory panel had overwhelmingly recommended the drug for approval in March 2009 based on those results. But two months later, the FDA said it would delay its decision pending receipt of further safety analysis.

Rivaroxaban given for 35 days subsequently reduced the risk of venous thrombosis compared with enoxaparin over 10 days in the MAGELLANtrial, which enrolled patients hospitalized with a range of acute conditions, including infections, stroke, cancer, and heart failure. Rivaroxaban was associated with more "nonmajor" bleeding compared with the low-molecular-weight heparin, however.

Of note, rivaroxaban is the first factor Xa inhibitor and so far the only oral anticoagulant approved in the US for orthopedic surgery. Dabigatran, which has the further distinction of requiring twice-daily dosing, is approved in other countries for that indication, but not here. That's also true for another factor Xa inhibitor, apixaban (Eliquis, Bristol-Myers Squibb/Pfizer).

As for the setting of stroke prevention in atrial fibrillation (AF), as covered by heartwire, rivaroxaban recently emerged as noninferior to warfarin in the >14 000-patient ROCKET AF trial. And apixaban performed well in AF against warfarin in the ARISTOTLEtrial, according to a preliminary announcement, although full details have yet to be formally presented anywhere. Dabigatran is currently available in the US for stroke prophylaxis in AF based on the >18 000-patient RE-LYtrial.

1. Janssen Pharmaceuticals. FDA approves Xarelto (rivaroxaban tablets) to help prevent deep vein thrombosis in patients undergoing knee or hip replacement surgery [press release]. July 2, 2011. Available here.

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