Xarelto filed with FDA for a supplemental approval in peripheral artery disease.- Janssen

The Janssen Pharmaceutical Companies of Johnson & Johnson has submitted a supplemental New Drug Application (sNDA) to the FDA for a new indication to expand the use of Xarelto (rivaroxaban) in patients with peripheral artery disease (PAD). If approved, this new indication for the Xarelto vascular dose (2.5 mg twice daily plus aspirin 75-100 mg 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, a common procedure in which blood flow is restored to the legs and feet due to symptomatic PAD. The application is based on data from the VOYAGER PAD study, which showed Xarelto (2.5 mg twice daily) plus aspirin (100 mg once daily) was superior to aspirin alone in reducing the risk of major cardiovascular (CV) and limb events, with similar rates of Thrombolysis In Myocardial Infarction (TIMI) major bleeding.