MHLW (Japan) approves Xarelto + aspirin to treat peripheral artery disease.
The Ministry of Health, Labor and Welfare in Japan has approved the use of the oral Factor Xa inhibitor rivaroxaban (Xarelto) (2.5 mg twice daily, used in combination with aspirin 81-100 mg once daily) 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 is 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).
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