Results from a Phase 3 clinical trial, EINSTEIN-Jr., evaluating a body weight-adjusted 20 mg equivalent dose of Bayer’s (OTCPK:BAYRY) blood thinner XARELTO (rivaroxaban) in children from birth to age 17 for the prevention of recurrent venous thromboembolism (VTE) showed comparable efficacy and safety to studies in adults. The data were presented at the International Society on Thrombosis and Hemostasis Congress in Melbourne.
Only 1.2% (n=4/335) of treated children experienced recurrent VTE compared to 3.0% (n=5/165) in those receiving standard-of-care (SOC) treatment (heparin alone or with a vitamin K antagonist).
The rate of clinically relevant bleeding in the treatment group was 3.0% (n=10/335) versus 1.9% (n=3/158) in the SOC arm.
A marketing application in Europe for the expanded use is next up.
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