Janssen Pharmaceuticals has announced that the FDA has approved the 10mg once-daily dose of rivaroxaban (Xarelto) for reducing the continued risk for recurrent venous thromboembolism (VTE) after completing at least six months of initial anticoagulation therapy.
The approval follows a FDA Priority Review and is based on data from EINSTEIN CHOICE, which found that a factor Xa inhibitor, specifically rivaroxaban, demonstrates superior efficacy in reducing the continued risk of recurrent VTE and with major bleeding rates similar to aspirin.
“We believe the availability of the 10mg Xarelto dose will change clinical practice and the management of VTE recurrence,” said 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 rivaroxaban prescribing information provides instructions for physicians to begin treatment with rivaroxaban 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 rivaroxaban 20mg once daily. After at least 180 days, physicians can prescribe rivaroxaban 10mg once daily in patients at continued risk for DVT and/or PE.
“If anticoagulation therapy is stopped, up to 20% 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 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 EINSTEIN CHOICE study evaluated patients with VTE who were already treated with six to 12 months of initial anticoagulation therapy and then received rivaroxaban 10mg once daily, rivaroxaban 20mg once daily or aspirin 100mg once daily for up to an additional 12 months of treatment. Patients taking either rivaroxaban dose had significantly fewer recurrent VTE compared to those taking aspirin. Specifically, rivaroxaban 10mg reduced the risk of recurrent VTE by 74% and rivaroxaban 20mg by 66%. All three treatment groups had low rates of major bleeding (0.4% with rivaroxaban 10mg, 0.5% with rivaroxaban 20mg, 0.3% with aspirin).
In September 2017, Janssen’s development partner Bayer announced the Committee for Medicinal Products for Human Use of the European Medicines Agency granted a positive opinion to update the Xarelto label to include the 10mg once-daily dose in the European Union; the European Commission granted approval on 19 October 2017.