XARELTO® is the first and only therapy indicated for both coronary artery disease (CAD) and PAD, now including PAD patients post-LER
XARELTO® is the only anticoagulant in 20 years to show significant benefit in patients with PAD who remain at high risk for major thrombotic events, including acute limb ischemia and amputation
PAD impacts 20 million Americans1 and is the leading cause of amputations in the U.S., with rates continuing to rise.
RARITAN, N.J., August 24, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded peripheral artery disease (PAD) indication for the XARELTO® (rivaroxaban) vascular dose (2.5 mg twice daily plus aspirin 100 mg once daily) to include patients following recent lower-extremity revascularization (LER) due to symptomatic PAD. The approval is based on data from the Phase 3 VOYAGER PAD study. With this approval, XARELTO® is the first and only therapy indicated to help reduce the risks of major cardiovascular (CV) events in patients with coronary artery disease (CAD) and major thrombotic vascular events, such as myocardial infarction, ischemic stroke, acute limb ischemia, and major amputation of a vascular etiology, in patients with PAD, including patients who have recently undergone LER due to symptomatic PAD.
[For more than 20 years, many physicians have used dual antiplatelet therapy after lower extremity revascularization due to symptomatic PAD with limited data to support efficacy and safety in this setting. Now, the VOYAGER PAD and COMPASS clinical studies have demonstrated the utility of dual pathway inhibition in targeting both platelets and thrombin in patients with PAD. These data provide a new mechanism of treatment using an evidence-based strategy for this vulnerable population," said Marc P. Bonaca*, M.D., M.P.H., Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado. [This FDA approval of rivaroxaban plus aspirin is a major advancement for PAD management and sets the stage to evolve the current standard of care for patients with PAD."
XARELTO® now has nine indications in the U.S. – the most of any direct oral anticoagulant (DOAC). Today`s approval is based on the Phase 3 VOYAGER PAD trial, which demonstrated the XARELTO® vascular dose (2.5 mg twice daily plus aspirin 100 mg once daily) reduced the risk of major adverse limb and cardiovascular events by 15 percent in patients with symptomatic PAD post-LER compared to aspirin alone.9 The VOYAGER PAD trial saw no significant difference in TIMIi major bleeding between XARELTO® with aspirin compared to aspirin alone. The results from the VOYAGER PAD study complement findings from the landmark Phase 3 COMPASS trial, which also examined the dual pathway approach of XARELTO® with aspirin in CAD and/or PAD patients and further supports this FDA label extension in PAD patients.10 Data from the Phase 3 COMPASS trial resulted in FDA approval in 2018 to reduce the risk of major cardiovascular events, such as heart attack, stroke and cardiovascular death in people with chronic PAD and CAD.10 While there were more major bleeds with the XARELTO® vascular dose in COMPASS, there was no significant difference in rates of fatal bleeding, intracranial bleeding or symptomatic bleeding into a critical organ.
