Pediatric patients currently have limited therapeutic options available / Granules for oral suspension of rivaroxaban that does not require regular coagulation monitoring has been developed and approved to facilitate pediatric administration /Pediatric use is based on the largest pediatric thromboembolism program completed to date, EINSTEIN-Jr.
Berlin, January 22, 2021 – The Ministry of Health, Labor and Welfare in Japan has approved the use of the oral Factor Xa inhibitor rivaroxaban (Xarelto™) to treat VTE and prevent VTE recurrence in children, including catheter related thrombosis, cerebral vein and sinus thrombosis. The use of an oral suspension was also approved.
Rivaroxaban, already indicated for the treatment of VTE and the prevention of recurrence in adult patients, is the first oral Factor Xa Inhibitor approved for pediatric treatment and secondary prevention of VTE.
“The rivaroxaban regimen represents an advantageous alternative treatment for children with VTE – with a safety and efficacy profile based on data from the most extensive and comprehensive clinical study program completed to date in pediatric thromboembolism,” said Dr. Michael Devoy, Head of Medical Affairs & Pharmacovigilance of Bayer AG’s Pharmaceutical Division and Chief Medical Officer at Bayer.
The approval is based on data from a comprehensive clinical program, including the phase III EINSTEIN-Jr. study – the largest program completed to date investigating the treatment of pediatric patients with VTE.(1) Pediatric VTE typically occurs in children with life-threatening illnesses, and due to frequent hospitalizations often for extended periods of time, these patients are at an increased risk of VTE. Moreover, current pediatric treatment of VTE is based mainly on observational data and extrapolation from VTE studies in adults using injectable heparins and/or Vitamin K antagonists.
During the phase III EINSTEIN-Jr. study, following completion of least 5 days of anticoagulation with heparin, children in the rivaroxaban-arm received rivaroxaban, body weight adjusted equivalent to the 20 mg once daily adult dose used to treat deep vein thrombosis (DVT)/ pulmonary embolism (PE). These dosages were administered as tablets or as granules for oral suspension. This study demonstrated a numerically lower incidence of recurrent VTE in children treated with rivaroxaban, compared with standard of care (injections of heparin alone or switched to a vitamin K antagonist such as warfarin). With no difference seen in the primary safety endpoint of major or clinically relevant non major bleeding, the absolute and relative safety and efficacy results seen in the EINSTEIN-Jr. study are consistent with those from previous rivaroxaban studies in adults.(1)