Bayer’s Xarelto approved in the UK

Bayer’s oral factor Xa inhibitor Xarelto (rivaroxaban) has been approved in the UK to treat venous thromboembolism (VTE) and to prevent VTE recurrence in children.

Xarelto will become available to treat and prevent VTE recurrence in children from birth to below 18 years old, at least five days after initial parenteral anticoagulation treatment.

The approval comes on the heels of a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in November 2020.

The CHMP recommendation and EMA approval also apply to the UK.

“We are delighted that rivaroxaban is now approved for use in children with VTE and for the prevention of recurrent VTE in children in the UK,” said Brendon Gray, medical director at Bayer UK.

“This provides physicians with an alternative treatment option and the ability to manage this potentially life-threatening condition in a vulnerable patient population group,” he added.

According to Bayer, Xarelto is the first oral factor Xa inhibitor to be approved for the paediatric treatment and secondary prevention of VTE.

Paediatric VTE usually occurs in severely-ill children, who require frequent and extended hospitalisations. This increases the risk factor for developing VTE.

“This is great news for children and their parents in the UK. VTE in paediatrics is quickly becoming a well-recognised cause of significant morbidity and mortality in children as most children diagnosed with VTE have a serious underlying primary illness such as cancer,” said Dr Philip Connor, paediatric haematologist at Noah’s Ark Children’s Hospital for Wales.

“Paediatric patients now have a direct oral anticoagulant option that does not require regular injections or monitoring,” he added.