Posted by Michael Wonder on 29 Jun 2017
U.S. FDA grants priority review of Xarelto (rivaroxaban) sNDA for a 10 mg dose to reduce the risk of recurrent venous thromboembolism
28 June 2017 - Approval of 10 mg dose would provide physicians another option to customise patient treatment plans.
Janssen Research & Development announced today the U.S. FDA accepted for priority review a supplemental new drug application for Xarelto (rivaroxaban) to include a 10 mg once daily dose for reducing the risk of venous thromboembolism (VTE) after at least six months of standard anti-coagulant therapy.
This application is based on data from EINSTEIN CHOICE, which is the only study to find a non-vitamin K antagonist oral anticoagulant, 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.
