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Low-dose rivaroxaban granted priority review by FDA for VTE indication

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Janssen Pharmaceuticals announced the FDA has granted priority review for a supplemental New Drug Application for rivaroxaban to include a 10 mg once-daily dose for venous thromboembolism risk reduction after a minimum of 6 months of standard anticoagulant therapy.

A press release from Janssen states that approval of a 10-mg dose would provide additional options for customizing patient treatment plans.

“The FDA's acceptance of our sNDA for priority review marks another important step toward a potential shift in how people with VTE are managed over time," Paul Burton, MD, PhD, FACC, vice president of medical affairs for Janssen, said in the release. “This will broaden the physician's ability to customize treatment plans based on the needs of each patient."

According the release, the sNDA application for rivaroxaban (Xarelto) follows the results of the EINSTEIN CHOICE trial, which was presented at the American College of Cardiology 2017 Scientific Session and found rivaroxaban 10 mg and 20 mg were superior to aspirin in reducing risk for recurrent VTE, with comparable rates of major bleeding.

Disclosure: Burton is an employee of Janssen.