U.S. FDA Grants Priority Review of XARELTO (rivaroxaban) sNDA for a 10 mg Dose to Reduce the Risk of Recurrent Venous Thromboembolism

RARITAN, N.J., June 28, 2017 /PRNewswire/ -- Janssen Research & Development, LLC announced today the U.S. Food and Drug Administration (FDA) accepted for Priority Review a supplemental New Drug Application (sNDA) for XARELTO® (rivaroxaban) to include a 10 mg once-daily dose for reducing the risk of 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.

VTE includes deep vein thrombosis (DVT), a blood clot in a deep vein (often in the legs), and pulmonary embolism (PE), a clot that travels to the lung.i Once anticoagulant therapy is stopped, up to 10 percent of people will experience a recurrence during the first year and up to 20 percent within three years.ii

"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, MD, PhD, FACC, Vice President, Medical Affairs, Janssen. "We are pleased the FDA sees the urgency in offering the choice of a 10 mg dose of XARELTO® or the currently approved 20 mg dose. This will broaden the physician's ability to customize 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 (PDUFA) target date to October 28, 2017.  

Data from the EINSTEIN CHOICE study support this sNDA. This phase 3, 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.iii 

XARELTO® currently has six indications approved by the FDA, including the treatment of VTE (15 mg twice daily for the first 21 days followed by 20 mg once daily for the remainder of treatment), and reduction in the risk of recurrent VTE (20 mg once daily).