Rivaroxaban receives peripheral arterial disease indication in Europe and USA

Rivaroxaban (brand name Xarelto; Bayer)

Rivaroxaban (brand name Xarelto, Bayer) has received approval from the US Food and Drug Administration (FDA) and the European Commission to reduce risks in peripheral arterial and chronic coronary disease patients. The oral anticoagulant is indicated in combination with aspirin, and is now the first and only Factor Xa inhibitor approved for patients living with these conditions.

Both approvals are based on results from the landmark COMPASS trial, which showed a significant 24% reduction of the risk of major CV events in patients with chronic coronary arterial disease (CAD) and/or peripheral arterial disease (PAD) with a 2.35mg vascular dose of rivaroxaban twice daily plus aspirin 100mg once daily, compared to aspirin alone. This finding was driven by a 42% reduction in stroke, 22% reduction in cardiovascular (CV) death, and 14% reduction in heart attack. The risk of major bleeding was significantly higher in patients taking the rivaroxaban/ aspirin regimen compared to aspirin alone, with no significant increase in fatal or intracranial bleeds.

Derek Connolly, consultant interventional cardiologist at Birmingham City Hospital (Birmingham, UK) and COMPASS trial investigator commented: “Cardiovascular diseases are one of the leading causes of death in the UK, and coronary artery disease and peripheral arterial 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 license 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.

“Despite the use of guideline-recommended therapies, patients with chronic CAD and/ or irreversible CV event,” said Paul Burton, vice president, Medical Affairs. “The new Xarelto vascular 2.5mg dose, when used with aspirin, represents a true breakthrough for patients with chronic CAD and PAD.”

“Treating patients with aspirin only is simply not enough to address the underlying thrombotic risk that comes with chronic CAD and PAD,” said Kelley Branch, associate professor in Cardiology, University of Washington, Seattle, USA. “As we saw in the COMPASS trial, the dual pathway approach of aspirin and the 2.5mg, twice-daily dose of Xarelto can help significantly reduce the risk of CV events in these populations.”


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