Janssen has submitted a supplemental New Drug Application (sNDA) to update the prescribing information for Xarelto (rivaroxaban) in order to add a 10mg dose to reduce the risk of recurrent venous thromboembolism (VTE) after at least 6 months of standard anticoagulation therapy.
The new sNDA submission is supported by the ‘Einstein Choice’ study, which included 3,365 patients in a Phase 3 randomized, double-blind study that compared 10mg and 20mg of Xarelto once daily with aspirin 100mg once daily, for the continued management of VTE in patients with confirmed DVT or PE who were initially treated with anticoagulation therapy for 6 to 12 months.
Results found that the study met its primary endpoint of both doses of Xarelto being superior to aspirin in reducing the risk of recurrent VTE.
“Our hope is to offer two dose options for continued treatment with Xarelto to the many people at risk of having another VTE,” said Paul Burton, MD, PhD, FACC, Vice President, Medical Affairs, Janssen.
If approved, healthcare professionals will be able to prescribe either Xarelto 10mg (once daily) or the currently-approved 20mg dose (once daily) after patients have received at least six months of standard anticoagulation therapy.
For more information visit NEJM.org.