Bayer announces new licensed indication for use of Xarelto® (rivaroxaban) in patients with coronary or peripheral artery disease

Published
Friday, August 24, 2018

Xarelto, co-administered with aspirin, is indicated in the EU for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events

  • Xarelto is the only non-vitamin K antagonist oral anticoagulant (NOAC) indicated in combination with aspirin (acetylsalicylic acid / ASA) for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events
  • CAD remains one of the UK’s leading causes of death – more than 66,000 patients die in the UK each year1. PAD is estimated to affect 1 in 5 people over 60 in the UK2

Reading, August 24, 2018 – Today, the European Commission (EC) approved a combination of Xarelto® (rivaroxaban) 2.5 mg twice daily plus low dose aspirin (acetylsalicylic acid / ASA) once daily for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events.

The EU approval is based on data from the COMPASS study, the largest Phase III study with rivaroxaban (27,395 patients), which showed that the rivaroxaban vascular dose, 2.5 mg twice daily, plus ASA 100 mg once daily reduced the risk of the composite of stroke, cardiovascular (CV) death and heart attack by 24% (relative risk reduction, ARR: 1.3%) compared with ASA 100 mg once daily alone in patients with CAD and/or PAD3.

Dr Derek Connolly, Consultant Interventional Cardiologist at Birmingham City Hospital and COMPASS trial investigator commented: “Cardiovascular diseases are one of the leading causes of death in the UK, and coronary artery disease and peripheral artery disease represent a major public health burden – despite many advances in the area of cardiovascular care, CAD and PAD have remained an area of unmet need. Even with currently available treatments for secondary prevention, patients remain at an unacceptably high risk of thrombotic events which can lead to disability, loss of limb and death. This was the biggest study of rivaroxaban to date, and now that it is licensed for these conditions, it provides UK clinicians with a new option for treating CAD and PAD.”

Lars Bruening, CEO Bayer UK & Ireland, said: “The story and momentum behind the COMPASS data continues to grow – from the study being stopped one year early for overwhelming efficacy, the presentation of the results themselves at the European Society of Cardiology congress last year, and now to this exciting news from the European Commission. Ten years ago this October saw Bayer just starting out on the Xarelto journey with the first indication in orthopaedics – and this year we welcome our eighth indication for the management of patients with CAD and PAD in the UK. It is especially exciting to see the continuing impact that Xarelto will have on patients with PAD, most of whom have concurrent CAD, as it has been many years since a new medical therapy has been proven in this high risk patient population.”

Following the licence approval across Europe, the new indication will be submitted to the National Institute for Health and Care Excellence (NICE) and the Scottish Medicines Consortium (SMC) for review for routine reimbursement across the UK.

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 effects you may get. See www.mhra.gov.uk/yellowcard for how to report side effects.

References

  1. CVD statistics – BHF UK Factsheet. Available at: https://www.bhf.org.uk/-/media/files/...statistics/bhf-cvd-statistics---... [Last accessed August 2018]
  2. British Heart Foundation. Focus on: Peripheral arterial disease (PAD). Available at: https://www.bhf.org.uk/informationsupport/heart-matters-magazine/medical... [Last accessed August 2018]
  3. Eikelboom, JW., et al. N Engl J Med 2017; 377:1319–30.