Bayer has received approval for the use of its oral Factor Xa inhibitor Xarelto®▼(rivaroxaban) to treat VTE and to prevent VTE recurrence in children from birth to below 18 years after at least 5 days of initial parenteral anticoagulation treatment, including catheter related thrombosis, cerebral vein and sinus thrombosis. The use of a new formulation and strength granules for oral suspension 1mg/ml was also approved.
Rivaroxaban is the first oral Factor Xa Inhibitor approved for paediatric treatment and secondary prevention of VTE. Paediatric VTE typically occurs in severely ill children who need frequent hospitalisations for extended periods of time, leading to these patients being at an increased risk of VTE.
The approval follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency in November 2020, which recommended approval in the European Union. This CHMP recommendation and approval also apply to the UK.