Bayer's Xarelto gets new UK approval

Xarelto (rivaroxaban) has been approved in the UK to treat venous thromboembolism (VTE) and to prevent VTE recurrence in children from birth to below 18 years after at least five 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 of the Factor Xa inhibitor was also approved.
Bayer’s (BAYN: DE) blood thinner is the first oral Factor Xa Inhibitor approved for pediatric treatment and secondary prevention of VTE. Pediatric VTE typically occurs in severely ill children who need frequent hospitalizations for extended periods of time, leading to these patients being at an increased risk of VTE.

"Pediatric patients now have a direct oral anticoagulant option that does not require regular injections or monitoring"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.