Most recent update: Sunday, April 29, 2018 - 14:56

You are here

Product approval

FDA approves 10mg dosing for Xarelto for VTE treatment

Xarelto is the only Factor Xa inhibitor to demonstrate superior efficacy in reducing the continued risk of recurrent VTE after initial treatment and with major bleeding rates similar to aspirin

Janssen Pharmaceuticals has announced that the FDA approved the 10mg once-daily dose of Xarelto (rivaroxaban) for reducing the continued risk for recurrent venous thromboembolism (VTE) after completing at least six months of initial anticoagulation therapy. This approval follows a FDA Priority Review and is based on data from EINSTEIN CHOICE, the only clinical study to find that a Factor Xa inhibitor, specifically Xarelto, demonstrated superior efficacy in reducing the continued risk of recurrent VTE and with major bleeding rates similar to aspirin.

"We believe the availability of the 10 mg Xarelto dose will change clinical practice and the management of VTE recurrence," said Dr Paul Burton, Vice President, Medical Affairs, Janssen. "The landmark EINSTEIN programme results yet again demonstrate Xarelto is a safe and highly effective option, not only for the initial treatment of a VTE, but also for the continued prevention of a recurrent event."

With this approval, the Xarelto prescribing information provides instructions for physicians to begin treatment with Xarelto 15mg, dosed twice daily, for the first 21 days after a VTE occurrence. On day 22 through at least day 180, the daily dose decreases to Xarelto 20 mg once daily. After at least 180 days (six months), physicians can prescribe Xarelto 10mg once daily in patients at continued risk for DVT and/or PE.

"If anticoagulation therapy is stopped, up to 20 percent of patients will have a recurrent VTE within three years. To prevent this, physicians have long debated how best to extend anticoagulant use beyond the initial treatment window," said Dr Jeffrey Weitz, Professor, Departments of Medicine and Biochemistry and Biomedical Sciences, McMaster University, and Executive Director, Thrombosis & Atherosclerosis Research Institute. "The FDA's approval of the 10mg dose of Xarelto for preventing recurrent VTE, along with clinical evidence confirming the superiority of Xarelto over aspirin for extended VTE prevention, means we can finally put this debate to rest."

The FDA's approval of the Xarelto 10mg once-daily dose was based on the EINSTEIN CHOICE study results. The EINSTEIN CHOICE study evaluated patients with VTE who were already treated with six to 12 months of initial anticoagulation therapy and then received Xarelto 10mg once daily, Xarelto 20mg once daily or aspirin 100 mg once daily for up to an additional 12 months of treatment. Patients taking either Xarelto dose had significantly fewer recurrent VTE compared to those taking aspirin. Specifically, Xarelto 10mg reduced the risk of recurrent VTE by 74 percent and Xarelto 20mg by 66 percent. All three treatment groups had low rates of major bleeding (0.4 percent with Xarelto 10mg, 0.5 percent with Xarelto 20mg, 0.3 percent with aspirin).

EINSTEIN CHOICE is a Phase 3, global, randomised, double-blind, superiority study that compared the efficacy and safety of two doses of Xarelto (10mg and 20mg once daily) with aspirin 100mg once daily for the management of VTE. The study met its primary efficacy endpoint, finding both Xarelto doses to be superior to aspirin in reducing the risk of recurrent VTE. There were 3,365 patients from 31 countries included in the study analysis. People who required extended anticoagulation at therapeutic doses were not included, as the study's objective was to investigate patients for whom the treating physician was uncertain about the need for continuing anticoagulant therapy.