FDA Clears Rivaroxaban (Xarelto) for Extended VTE Prevention

Megan Brooks

October 30, 2017

TITUSVILLE, NJ — Rivaroxaban (Xarelto, Janssen) 10 mg once daily has been cleared by the US Food and Drug Administration (FDA) for reducing the ongoing risk for recurrent venous thromboembolism (VTE) following at least 6 months of initial anticoagulation therapy, the company said today[1].

Rivaroxaban is a factor Xa oral anticoagulant used to treat and prevent deep vein thrombosis (DVT) and/or pulmonary embolism (PE), as well as stroke prevention in the setting of atrial fibrillation.

According to the company, with today's new approval, the rivaroxaban prescribing information now advises beginning the drug at 15 mg dosed twice daily for the first 21 days after VTE and decreasing the dose to 20 mg once daily on day 22 through at least day 180. After at least 180 days, physicians may now prescribe rivaroxaban 10 mg once daily in patients at continued risk for VTE, the company said.

The FDA gave priority review to rivaroxaban 10 mg once daily following at least 6 months of initial treatment based on data from the EINSTEIN CHOICE trial presented at the American College of Cardiology (ACC) 2017 Scientific Sessions and published in the New England Journal of Medicine.

As previously reported by theheart.org | Medscape Cardiology, in patients with VTE who had completed 6 to 12 months of anticoagulation therapy but for whom it was uncertain as to whether longer-term treatment was needed, extended therapy with rivaroxaban was more effective than aspirin in preventing recurrent VTE without an increased risk of bleeding.

"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," Dr Jeffrey Weitz (McMaster University, Hamilton, ON) said in a Janssen news release.

"The FDA's approval of the 10-mg 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," said Weitz.

Another factor Xa inhibitor, apixaban (Eliquis, Bristol-Myers Squibb/Pfizer), may also be given after an initial treatment period of 6 months to reduce ongoing risk of recurrent DVT and PE.

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