Posted by Michael Wonder on 26 Oct 2020
Janssen submits application to U.S. FDA for new indication to expand use of Xarelto (rivaroxaban) in patients with peripheral artery disease
26 October 2020 - Application seeks approval of Xarelto plus aspirin to reduce the risk of major thrombotic vascular events in patients after lower-extremity revascularisation due to symptomatic peripheral artery disease.
Janssen announced today it has submitted a supplemental new drug application to the U.S. FDA for a new indication to expand the use of Xarelto (rivaroxaban) in patients with peripheral artery disease.
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 and limb events, with similar rates of thrombolysis in myocardial infarction major bleeding.
