FDA accepts priority review for Xarelto (rivaroxaban) in venous thromboembolism- Janssen

The FDA has accepted for Priority Review a supplemental New Drug Application (sNDA) for Xarelto (rivaroxaban), from Janssen, to include a 10 mg once-daily dose for reducing the risk of venous thromboembolism (VTE) after at least six months of standard anticoagulant therapy. This application is based on data from EINSTEIN CHOICE, which is the only study to find a non-vitamin K antagonist oral anticoagulant (NOAC), specifically two doses of Xarelto (10 mg and 20 mg), to be superior to aspirin in reducing the risk of recurrent VTE, with comparable rates of major bleeding.

Data from the EINSTEIN CHOICE study support this sNDA. This phase III, global, randomized, double-blind, superiority study met its primary efficacy endpoint, finding both Xarelto doses (10 mg and 20 mg) to be superior to aspirin in reducing the risk of recurrent VTE following at least a 6 months of standard anticoagulation therapy. Specifically, Xarelto 10 mg reduced the risk of recurrent VTE by 74 percent and Xarelto 20 mg by 66 percent. All three treatment groups had low rates of major bleeding.