Janssen applies to FDA for new indication to expand use of rivaroxaban in PAD patients

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Xarelto (rivaroxaban)

The Janssen Pharmaceutical Companies of Johnson & Johnson announced today it has submitted a supplemental New Drug Application (sNDA) to the Food and Drug Administration (FDA) for a new indication to expand the use of Xarelto (rivaroxaban) in patients with peripheral arterial disease (PAD).

If approved, this new indication for the Xarelto vascular dose (2.5mg twice daily plus aspirin 75–100mg once daily) would include reducing the risk of major thrombotic vascular events such as heart attack, stroke, and amputation in patients after recent lower extremity revascularization.

The application is based on data from the VOYAGER PAD study, which showed Xarelto (2.5mg twice daily) plus aspirin (100mg once daily) was superior to aspirin alone in reducing the risk of major cardiovascular and limb events, with similar rates of thrombolysis in myocardial infarction (TIMI) major bleeding.

“Various antithrombotic regimens have been evaluated for short- and long-term prevention of major vascular events in patients with PAD, but only rivaroxaban in combination with aspirin has demonstrated a significant benefit over aspirin alone,” said James List, global therapeutic area head, Cardiovascular & Metabolism, Janssen Research & Development.

“Data from the VOYAGER PAD trial were the first in 20 years to show clinical benefit with an antithrombotic therapy in the symptomatic PAD population after lower-extremity revascularization, which speaks to the need for a new treatment in this space. We look forward to discussing these data with the FDA.”

Janssen and its development partner Bayer have conducted two major phase 3 trials—VOYAGER PAD and COMPASS—that evaluated the use of dual antithrombotic pathway inhibition with Xarelto plus aspirin in patients with PAD. Xarelto, in combination with aspirin, was approved by the FDA in 2018 to reduce the risk of major cardiovascular events in patients with chronic PAD and coronary artery disease.

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