The US Food and Drug Administration (FDA) has accepted, for priority review, a supplemental new drug application (sNDA) for Janssen’s Xarelto (rivaroxaban), to include a 10mg 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, specifically two doses of Xarelto (10mg and 20mg), to be superior to aspirin in reducing the risk of recurrent VTE, with comparable rates of major bleeding.
VTE includes deep vein thrombosis (DVT) and pulmonary embolism (PE). Once anticoagulant therapy is stopped, up to 10% of people will experience a recurrence during the first year and up to 20% within three years.
“The FDA’s acceptance of our sNDA for priority review marks another important step toward a potential shift in how people with VTE are managed over time,” said Paul Burton, vice president of Medical Affairs at Janssen. “We are pleased the FDA sees the urgency in offering the choice of a 10mg dose of Xarelto or the currently approved 20mg dose. This will broaden the physician’s ability to customise treatment plans based on the needs of each patient.”
The FDA grants priority review to medicines that may offer significant improvements in the treatment, diagnosis or prevention of a serious condition. This designation shortens the review period to six months compared to 10 months for standard review. This accelerated review advances the FDA’s prescription drug user fee act target date to 28 October, 2017.
Data from the EINSTEIN CHOICE study support this sNDA. This phase 3, global, randomised, double-blind, superiority study met its primary efficacy endpoint, finding both Xarelto doses (10mg and 20mg) to be superior to aspirin in reducing the risk of recurrent VTE following at least six months of standard anticoagulation therapy. Specifically, Xarelto 10mg reduced the risk of recurrent VTE by 74% and Xarelto 20mg by 66%. All three treatment groups had low rates of major bleeding.
Xarelto currently has six indications approved by the FDA, including the treatment of VTE (15mg twice daily for the first 21 days followed by 20mg once daily for the remainder of treatment), and reduction in the risk of recurrent VTE (20mg once daily).