FDA approves expanded PAD indication for Xarelto plus aspirin to include patients after LER due to symptomatic PAD

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Xarelto (rivaroxaban)

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the US Food and Drug Administration (FDA) has approved an expanded peripheral arterial disease (PAD) indication for the Xarelto (rivaroxaban) vascular dose (2.5mg twice daily plus aspirin 100mg once daily) to include patients following recent lower-extremity revascularisation (LER) due to symptomatic PAD.

The approval is based on data from the Phase III VOYAGER PAD study. According to a press release, Xarelto is now the first and only therapy indicated to help reduce the risks of major cardiovascular events in patients with coronary artery disease (CAD) and major thrombotic vascular events, such as myocardial infarction, ischaemic stroke, acute limb ischaemia, and major amputation of a vascular aetiology, 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 revascularisation 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 (University of Colorado Anschutz Medical Campus, Aurora, USA). “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 USA. Today’s approval is based on the Phase III VOYAGER PAD trial, which demonstrated the Xarelto vascular dose (2.5mg twice daily plus aspirin 100mg once daily) reduced the risk of major adverse limb and cardiovascular events by 15% in patients with symptomatic PAD post-LER compared to aspirin alone. The VOYAGER PAD trial saw no significant difference in Thrombolysis in Myocardial Infarction (TIMI) major bleeding between Xarelto with aspirin compared to aspirin alone.

The results from the VOYAGER PAD study complement findings from the landmark Phase III 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. Data from the Phase III 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.  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.


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