FDA OKs 10 mg Rivaroxaban
This approval follows a FDA priority review and is based on data from EINSTEIN CHOICE, the only clinical study to note that a Factor Xa inhibitor demonstrates superior efficacy in reducing the continued risk of recurrent VTE and with major bleeding rates similar to aspirin.
Officials with the FDA have approved 10 mg once-daily dose of rivaroxaban (Xarelto, Janssen Pharmaceuticals, Inc.) for reducing the continued risk for recurrent venous thromboembolism (VTE) after completing at least 6 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 note that a Factor Xa inhibitor demonstrates superior efficacy in reducing the continued risk of recurrent VTE and with major bleeding rates similar to aspirin. The EINSTEIN CHOICE study evaluated patients with VTE who were already treated with 6 to 12 months of initial anticoagulation therapy and then received Xarelto either 10 mg once daily, 20 mg once daily or aspirin 100 mg once daily for up to an additional year of treatment. Patients taking either Xarelto dose had significantly fewer recurrent VTE compared to those taking aspirin.
With this approval, the Xarelto prescribing information provides instructions for physicians to begin treatment with Xarelto 15 mg, 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 20 mg once daily. After at least 180 days (6 months), physicians can prescribe 10 mg 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 3 years. To prevent this, physicians have long debated how best to extend anticoagulant use beyond the initial treatment window," Jeffrey Weitz, MD, FRCP(C), FACP, Professor, Departments of Medicine and Biochemistry and Biomedical Sciences, McMaster University, and Executive Director, Thrombosis & Atherosclerosis Research Institute said in a press release about the approval. "The FDA's approval of the 10 mg dose 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."
FDA Approves New 10 mg Dosing for XARELTO® (rivaroxaban) to Reduce the Continued Risk of Venous Thromboembolism (VTE) [news release]. Titusville, NJ. Janssen Pharmaceuticals, Inc. October 30, 2017. https://www.prnewswire.com/news-releases/fda-approves-new-10-mg-dosing-for-xarelto-rivaroxaban-to-reduce-the-continued-risk-of-venous-thromboembolism-vte-300545364.html. Accessed October 30, 2017.