The Ministry of Health, Labor and Welfare in Japan has approved the use of the oral Factor Xa inhibitor rivaroxaban (Xarelto) to treat patients with peripheral artery disease (PAD) after revascularization. The approval is based on data from the Phase III VOYAGER PAD trial.

This study demonstrated a positive benefit-risk profile of starting Xarelto in combination with aspirin in patients with symptomatic PAD after a recent lower-extremity revascularization. It´s the first trial to demonstrate the benefits of dual pathway inhibition - with the anticoagulant Xarelto in combination with the antiplatelet aspirin - in these PAD patients at high risk of major adverse cardiovascular events (MACE) and especially major adverse limb events (MALE).

“This approval is an important advance for patients with PAD in Japan,” said Dr. Michael Devoy, Head of Medical Affairs & Pharmacovigilance of Bayer AG's Pharmaceuticals Division and Chief Medical Officer at Bayer. “Xarelto shows a significant benefit in patients with PAD who remain at high risk for major thrombotic events post lower extremity revascularization. They are suffering from a disease which often goes undiagnosed and undertreated.”

The Phase III VOYAGER PAD study included 6,564 patients from 542 sites across 34 countries worldwide. In the study, patients were randomized to receive either Xarelto 2.5 mg twice daily plus aspirin 100 mg once daily or aspirin 100 mg once daily alone. The primary efficacy endpoint was a composite of MALE and MACE, ie. acute limb ischemia, major amputation of a vascular etiology, heart attack (myocardial infarction, MI), ischemic stroke or cardiovascular death. The primary safety outcome was major bleeding according to the Thrombolysis in Myocardial Infarction (TIMI) classification.