WASHINGTON -- The FDA has approved rivaroxaban (Xarelto), an oral, once-daily, factor Xa inhibitor, for prevention of deep vein thrombosis in patients undergoing knee or hip replacement surgery, according to an announcement by Janssen Pharmaceuticals.
The drug is approved for use at a 10 mg dose, once a day for 35 days following hip replacement and for 12 days following knee replacement.
Rivaroxaban, which is also being developed for prevention of recurrent DVT and for prevention of stroke in patients with atrial fibrillation, is the second oral anticoagulant approved by the FDA within the last nine months.
Dabigatran (Pradaxa), a direct thrombin inhibitor, won FDA approval last October for prevention of stroke in patients with atrial fibrillation. It is not approved for DVT prophylaxis.
A third novel oral anticoagulant, apixaban (Eliquis), has also posted promising results in clinical trials and it is widely expected that an NDA for it will be submitted by year end.
Janssen said the FDA based its decision on data from the rivaroxaban phase III clinical development program in which the drug demonstrated greater efficacy than enoxaparin while demonstrating a similar safety profile "including low rates of major bleeding."
When compared with enoxaparin in EINSTEIN DVT, a study of more than 3,400 older adults with symptomatic DVT, rivaroxaban-treated patients had a significantly lower rate of recurrent DVT than warfarin-treated patients.
Likewise, in ROCKET-AF rivaroxaban was as effective as warfarin for preventing stroke in patients with Afib and boasted a slightly better safety profile.