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Updated labeling for rivaroxaban sought
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Janssen Research & Development announced it submitted a supplemental New Drug Application to the FDA seeking a new indication for rivaroxaban.
The company stated in a press release that it seeks to update the prescribing info for rivaroxaban (Xarelto, Janssen) to add a 10-mg dose to reduce risk for recurrent venous thromboembolism in patients who have received at least 6 months of standard anticoagulation therapy. The drug is currently approved at a 20-mg once-daily dose.
“For those people who have had a VTE and stop anticoagulant therapy, as many as 10% of them will experience another VTE within 1 year and 20% within 3 years,” Paul Burton, MD, PhD, FACC, vice president of medical affairs at Janssen, said in the release. “Our hope is to offer two dose options for continued treatment with Xarelto to the many people at risk of having another VTE.”
The application comes after the results of EINSTEIN CHOICE, presented at the American College of Cardiology Scientific Session, which showed that participants with VTE who received rivaroxaban 10 mg or 20 mg once daily for 12 months following 6 to 12 months of anticoagulation therapy had less recurrent VTE compared with those assigned aspirin.