Bayer HealthCare and its development partner Janssen Research & Development, LLC have announced an expansion of the global clinical development programme for the oral Factor Xa inhibitor, rivaroxaban, for the prevention of potentially deadly blood clots in patients at risk of venous and arterial thromboembolism (VAT):
- Patients who have suffered an embolic stroke of undetermined source (ESUS)
- Patients with peripheral artery disease (PAD) undergoing peripheral artery interventions
Rivaroxaban, Xarelto®, has already been approved for five indications in seven distinct areas of use, protecting patients across more venous and arterial thromboembolic conditions than any other novel oral anticoagulant (NOAC). Yet the global burden of thrombosis-related diseases remains significant in a number of areas of unmet medical need. While the on-going programme for rivaroxaban, including Phase III studies like COMPASS1, COMMANDER-HF2, MARINER3, and EINSTEIN CHOICE4, addresses some of these, the medical need in key additional areas is still high.
Two Phase III indication-seeking studies will investigate as follows:
ESUS accounts for approximately 25% of ischaemic strokes5, but there is limited knowledge or data available to guide treatment decisions regarding the secondary prevention of stroke in these patients. "The ROCKET AF study showed that once-daily rivaroxaban was effective and well-tolerated among patients who have non-valvular atrial fibrillation (AF) with and without previous stroke or transient ischaemic attack," said Dr Robert G. Hart, Professor of Neurology, McMaster University, Hamilton, Ontario, Canada. "Based on the findings from ROCKET AF, we will investigate the potential clinical value of once-daily rivaroxaban in preventing recurrence of stroke in patients with embolic stroke of undetermined source - an important unmet need in stroke prevention."
Peripheral artery disease (PAD) VOYAGER PAD will explore the potential benefits of rivaroxaban in reducing thrombotic vascular complications in patients with peripheral artery disease undergoing peripheral artery interventions. This global Phase III indication-seeking study will enrol more than 5,000 patients across more than 20 countries.
PAD affects approximately 202 million people worldwide6, and the progressive build-up of plaque inside the arteries can slowly reduce the blood flow to the limbs and the heart. Patients with PAD are not only at an increased risk of atherothrombotic events such as stroke, heart attack, or cardiovascular death, but also of amputations and acute limb ischaemia. "Building on the results of the ATLAS ACS 2-TIMI 51 study in acute coronary artery disease, this study will investigate whether rivaroxaban can provide similar protection to patients with symptomatic PAD undergoing peripheral revascularisation procedures," said Prof William R. Hiatt, Professor of Cardiology, University of Colorado School of Medicine, President CPC Clinical Research, Denver, USA.
"Together with our partner Janssen, we are committed to further investigate the potential benefits of rivaroxaban in areas of significant unmet medical need," said Dr Joerg Moeller, Member of the Bayer HealthCare Executive Committee and Head of Global Development. "Rivaroxaban is already approved to prevent and treat more venous and arterial thromboembolic conditions than any other NOAC. However, areas of unmet medical need still exist where rivaroxaban could potentially benefit even more patients at risk of the serious and often life-threatening diseases caused by blood clots."
The extensive evaluation of rivaroxaban to protect different patient populations at risk of VAT makes it the most studied NOAC in the world. The investigation of rivaroxaban will include more than 275,000 patients in both clinical trials and real world settings.