FDA Approves New 10 mg Dosing for XARELTO

The US Food and Drug Administration (FDA) has approved a 10 mg once-daily dose of rivaroxaban (XARELTO) for reducing the continued risk of recurrent venous thromboembolism (VTE) after completing at least 6 months of initial anticoagulation therapy, announced Janssen.

The approval of the 10 mg follows an FDA priority review from the supplemental new drug application submitted in April, and is based on data from EINSTEIN CHOICE.

“We believe the availability of the 10 mg XARELTO dose will change clinical practice and the management of VTE recurrence," Paul Burton, MD, PhD, FACC, vice president, medical affairs, Janssen, said in a statement. "The landmark EINSTEIN program 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."

EINSTEIN CHOICE is the only clinical study to find 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 study evaluated patients with VTE who were previously treated with 6—12 months of initial anticoagulation therapy and then received XARELTO 10 mg once daily, XARELTO 20 mg once daily or aspirin 100 mg once daily for up to an additional 12 months of treatment.

The study met its primary efficacy endpoint, finding that both XARLETO doses were superior to aspirin in reducing the risk of recurrent VTE.

Patients taking either XARELTO dose had significantly fewer recurrent VTE compared to those patients taking aspirin. Those taking the XARELTO 10 mg dose, reduced the risk of recurrent VTE by 74%, and XARELTO 20 mg by 66%.

All 3 arms had low rates of major bleeding, 0.4% with XARELTO 10 mg, 0.5% with XARELTO 20 mg, and 0.3% with aspirin.

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 6 months, physicians can prescribe XARELTO 10 mg once daily in patients with continued risk for deep vein thrombosis and/or pulmonary embolism.

VTE is the third most common cause of cardiovascular death worldwide, after heart attack and stroke.

A press release has been made available.