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, 2.5mg twice daily, plus ASA 100mg 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 100mg once daily alone in patients with CAD and/or PAD.
Birmingham City Hospital, (Birmingham, UK) consultant interventional cardiologist Derek Connolly and COMPASS trial investigator Derek Connolly said: “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.”
Bayer UK & Ireland CEO Lars Bruening 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.
Source: Company Press Release