FDA approves Xarelto to treat venous thromboembolism (VTE) and to prevent VTE in children. Bayer HealthCare.
Xarelto is the only Factor Xa anticoagulant FDA approved for primary prevention of clots in pediatric patients following the Fontan procedure and the only anticoagulant to offer a liquid formulation for flexible, body weight adjusted dosing options for pediatric patients. Current guideline options are limited and recommend treating pediatric patients with or at risk for reoccurrence of blood clots with standard anticoagulation therapy which requires injections or dietary restrictions, and regular laboratory monitoring.
Earlier this year, Xarelto was approved in Canada, the EU including UK, Japan, Switzerland and in various Latin American countries for the treatment of VTE and prevention of VTE recurrence in children and adolescents aged less than 18 years after at least 5 days of initial parenteral anticoagulation treatment.
The approval is based on evidence from three robust and well-controlled studies of Xarelto in adults (EINSTEIN DVT, PE and EXTENSION) with additional data from two Phase III clinical trials of Xarelto in pediatric patients: EINSTEIN-Jr., which examined pediatric patients with diagnosed VTE, and UNIVERSE, which evaluated pediatric patients who are at risk of VTE after recently undergoing the Fontan procedure.
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The FDA has approved two pediatric indications for Xarelto (rivaroxaban) from Bayer HealthCare, the treatment of venous thromboembolism (VTE) and reduction in the risk of recurrent VTE in patients from birth to less than 18 years after at least five days of initial parenteral (injected or intravenous) anticoagulant treatment; and thromboprophylaxis (prevention of VTE and VTE related events) in children aged two years and older with congenital heart disease who have undergone the Fontan procedure.
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