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Thrombus
The US Food and Drug Administration (FDA) has accepted for priority review a supplemental new drug application (sNDA) for rivaroxaban (XARELTO®).
The sNDA is for a 10 mg once-daily dose of rivaroxaban to reduce the risk of venous thromboembolism (VTE) in patients who have received at least 6 months of standard anticoagulant therapy.
The FDA grants priority review to applications for products that may provide significant improvements in the treatment, diagnosis, or prevention of serious conditions.
The agency’s goal is to take action on a priority review application within 6 months of receiving it, rather than the standard 10 months.
The FDA plans to make a decision on the rivaroxaban sNDA by October 28, 2017.
The sNDA is supported by data from the EINSTEIN CHOICE study. Patients enrolled in this study had confirmed VTE and were treated initially with standard anticoagulant therapy for 6 to 12 months.
During EINSTEIN CHOICE, 3365 patients received rivaroxaban at 10 mg, rivaroxaban at 20 mg, or aspirin at 100 mg once daily for up to 12 months of extended treatment.
Both rivaroxaban doses were superior to aspirin in preventing fatal or non-fatal recurrent VTE, the study’s primary efficacy endpoint.
The rate of recurrent VTE was 1.2% in the 10 mg rivaroxaban arm (hazard ratio [HR]=0.26; 95% CI, 0.14 to 0.47; P<0.001), 1.5% in the 20 mg rivaroxaban arm (HR=0.34; 95% CI, 0.20 to 0.59; P<0.001), and 4.4% in the aspirin arm. Fatal VTE occurred in 0%, 0.2%, and 0.2% of patients, respectively.
The primary safety endpoint was major bleeding as defined by the International Society on Thrombosis and Haemostasis.
The rate of major bleeding was 0.4% for the 10 mg rivaroxaban group (HR=1.64; 95% CI, 0.39 to 6.84; P=0.50), 0.5% for the 20 mg rivaroxaban group (HR=2.01; 95% CI, 0.50 to 8.04; P=0.32), and 0.3% for the aspirin group.
