News | Antiplatelet and Anticoagulation Therapies | June 29, 2017

FDA Grants Priority Review of Xarelto sNDA for 10 mg Dose

Approval of 10 mg dose to reduce the risk of recurrent venous thromboembolism would provide physicians another option to customize patient treatment plans

FDA Grants Priority Review of Xarelto sNDA for 10 mg Dose

June 29, 2017 — Janssen Research & Development LLC announced 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 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.

VTE includes deep vein thrombosis (DVT), a blood clot in a deep vein, and pulmonary embolism (PE), a clot that travels to the lung. 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.

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 Oct. 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 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.

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).

Read the related article "Advantages and Disadvantages of Novel Oral Anticoagulants."

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