Bayer’s venous thromboembolism drug Xarelto gets UK approval for children
pharmafile | February 1, 2021 | News story | Sales and Marketing | Bayer
Bayer has received UK approval for the use of its oral Factor Xa inhibitor Xarelto (rivaroxaban) to treat venous thromboembolism (VTE) and to prevent VTE recurrence in children aged below 18 after at least five days of initial parenteral anticoagulation treatment, including catheter related thrombosis, cerebral vein, and sinus thrombosis.
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 UK’s approval follows a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) in November last year, which recommended the drug’s approval in the EU. The CHMP’s recommendation and approval also apply to the UK.
The use of a new formulation and strength granules for oral suspension 1mg/ml was also approved.
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. Paediatric patients now have a direct oral anticoagulant option that does not require regular injections or monitoring.”
Brendon Gray, Medical Director at Bayer UK, also commented: “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.”
Darcy Jimenez
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