Bayer receives approval in the UK for Xarelto® (rivaroxaban) to treat children with venous thromboembolism (VTE) and to prevent VTE recurrence

Bayer receives approval in the UK for Xarelto^®  (rivaroxaban) to treat children with venous thromboembolism (VTE) and to prevent VTE recurrence

• Rivaroxaban is the first oral Factor Xa Inhibitor to be approved to treat children with VTE and to prevent VTE recurrence.^[1]

• Paediatric use of rivaroxaban is based on data from the phase III paediatric thromboembolism programme, EINSTEIN-Junior.^[2]

Reading, February 1^st, 2021 – 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.¹ The use of a new formulation and strength granules for oral suspension 1mg/ml was also approved.¹

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.^[3],[4]   

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.

Dr Philip Connor, Paediatric Haematologist at Noah's Ark Children's Hospital for Wales, said: “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.^[5] Paediatric patients now have a direct oral anticoagulant option that does not require regular injections or monitoring.”

“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. This provides physicians with an alternative treatment option and the ability to manage this potentially life-threatening condition in a vulnerable patient population group”, said Brendon Gray, Medical Director at Bayer UK.

Please see the Summary of Product Characteristics for Xarelto^® (rivaroxaban) for additional information.

Reporting of side effects:

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side affects you may get. See www.mhra.gov.uk/yellowcard for how to report side effects, or search for MHRA Yellow Card in Google Play or Apple App Store. Adverse events should also be reported to Bayer plc. Tel.: 0118 206 3500, Fax: 0118 206 3703, Email pvuk@bayer.com