December 21, 2021: ‘The U.S.FDA has approved two pediatric indications for Xarelto™ (rivaroxaban): 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.
“The approval of two new indications for Xarelto in the US is an important step in helping to address the burden of venous thromboembolism in a vulnerable patient population.
It will provide doctors with body weight-based dosing options in pediatric patients,” said Dr. Michael Devoy, Head of Medical Affairs & Pharmacovigilance of Bayer AG’s Pharmaceuticals Division and Chief Medical Officer at Bayer.
“The Xarelto suspension for oral use will obviate the need for adjustments of adult dosage forms and substantially reduce the number of injections needed for anticoagulation treatment and blood sampling.”
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.
EINSTEIN-Jr. is the largest study completed to date evaluating the treatment of pediatric patients with VTE, and UNIVERSE is the first clinical trial to examine a non-vitamin K antagonist oral anticoagulant (NOAC) for the prevention of thromboembolism in congenital heart disease post-Fontan pediatric patients.
About the EINSTEIN-Jr. Study
The randomized, open-label phase III EINSTEIN-Jr. study included 500 children aged from birth to below 18 years with documented acute VTE who had started heparin therapy for at least 5 days.
Children were assigned, in a 2:1 ratio, to receive body weight-adjusted rivaroxaban (tablets or oral suspension) in a 20 mg-equivalent dose, or standard of care with (low molecular weight) heparin, fondaparinux or vitamin K antagonist therapy.
The main treatment period was 3 months, but in children younger than 2 years with catheter related VTE it was 1 month.
Repeat imaging was carried out at the end of the treatment period. Results were also interpreted in the context of previous studies evaluating rivaroxaban in adults with VTE.”
