FDA to Review Lower Dose Xarelto for Recurrent VTE Risk Reduction

The sNDA includes data from a trial that involved 3,365 individuals
The sNDA includes data from a trial that involved 3,365 individuals

Janssen announced that the Food and Drug Administration (FDA) has granted Priority Review for a supplemental New Drug Application (sNDA) for Xarelto (rivaroxaban) to include a 10mg once daily dose for the reduction of venous thromboembolism (VTE) risk after ≥6 months of standard anticoagulant therapy. 

The sNDA included data from EINSTEIN CHOICE (n=3,365), a Phase 3 randomized, double-blind, superiority study that met its primary efficacy endpoint. Both doses of Xarelto (10mg and 20mg) were superior to aspirin (100mg) in lowering the risk of recurrent VTE after ≥6 months of standard anticoagulation. In the study, Xarelto 10mg reduced the risk by 74% and Xarelto 20mg by 66%. 

All three treatment arms exhibited comparable rates of major bleeding. EINSTEIN CHOICE is the only study to demonstrate the superiority of a non-vitamin K antagonist oral anticoagulant (NOAC) over aspirin in reducing the risk of recurrent VTE. 

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Xarelto, a Factor Xa inhibitor, is currently approved to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation; to treat deep vein thrombosis (DVT), pulmonary embolism (PE); to reduce the risk of recurrence of DVT, PE following 6 months treatment for DVT, PE; and as prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery.

The FDA has set a Prescription Drug User Fee Act (PDUFA) target date to October 28, 2017.

For more information call (800) 526-7736 or visit Xarelto.com.