FDA Grants Priority Review of 10-mg Dose of Xarelto to Reduce Risk of Recurrent VTE
June 28, 2017—Janssen Research & Development, LLC announced that the US Food and Drug Administration (FDA) accepted for priority review a supplemental new drug application for the company's Xarelto (rivaroxaban) to include a 10-mg once-daily dose for reducing the risk of venous thromboembolism (VTE) after at least 6 months of standard anticoagulant therapy. This application is based on data from EINSTEIN CHOICE, which found that two doses of Xarelto (10 and 20 mg), a nonvitamin K antagonist oral anticoagulant, were superior to aspirin in reducing the risk of recurrent VTE with comparable rates of major bleeding. Currently, the 20-mg dose of Xarelto is approved by the FDA.
The company noted that the FDA grants priority review to medicines that may offer significant improvements in the treatment, diagnosis, or prevention of a serious condition. This designation shortens the review period to 6 months compared to 10 months for standard review. This accelerated review advances the target date under the FDA's Prescription Drug User Fee Act to October 28, 2017.