READING, England--(BUSINESS WIRE)--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 firstname.lastname@example.org
About Paediatric Venous Thromboembolism (VTE)
Paediatric VTE includes cerebral vein and sinus thrombosis (a blood clot in the brain), central venous catheter related thrombosis, pulmonary embolism (a blood clot that travels to the lung), and deep vein thrombosis (a blood clot in a deep vein).
Due to improved diagnosis, treatment and survival rates amongst children with life-threatening or chronic medical conditions, as well as increased awareness among paediatricians, venous thromboembolism (VTE) is being identified more often in hospitalised children.3,4 The most common risk factor for VTE in children is venous catheterisation.4
Currently, recommended treatment options for VTE include unfractionated heparin, low molecular weight heparin, and fondaparinux with or without a vitamin K antagonist therapy.
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to benefit people by supporting efforts to overcome the major challenges presented by a growing and aging global population. At the same time, the Group aims to increase its earning power and create value through innovation and growth. Bayer is committed to the principles of sustainable development, and the Bayer brand stands for trust, reliability and quality throughout the world. In fiscal year 2019, the Group employed around 104,000 people and had sales of 43.5 billion euros. Capital expenditures amounted to 2.9 billion euros, R&D expenses to 5.3 billion euros. For more information, go to www.bayer.co.uk.
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
1 Xarelto, Summary of Product Characteristics (SmPC). Available at: https://ec.europa.eu/health/documents/community-register/html/h472.htm [Last Accessed, January 2021]
2 Male, C, et al, ‘Rivaroxaban compared with standard anticoagulants for the treatment of acute venous thromboembolism in children: a randomised, controlled, phase 3 trial’, The Lancet Haematology, 7.1 (2019), pp.18-27
3 Schneppenheim R, Greiner J. Thrombosis in infants and children. Hematology Am Soc Hematol Educ Program: doi:10.1182/asheducation-2006.1.86:86–96 (2006)
4 Witmer C et al. Pediatric Hospital Acquired Venous Thromboembolism, Front Pediatr. 2017; 5: 198. (2017)
5 Anton N, Massicotte M P, Venous thromboembolism in pediatrics, Semin Vasc Med. 2001;1(1):111-22. doi: 10.1055/s-2001-14548.
RP-XAR-GB-2833 / Date of prep: January 2021