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  • FDA gives expanded approval for Xarelto in periphe...

FDA gives expanded approval for Xarelto in peripheral artery disease.

Read time: 1 mins
Published:25th Aug 2021
The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the FDA has approved an expanded peripheral artery disease (PAD) indication for the Xarelto (rivaroxaban) vascular dose (2.5 mg twice daily plus aspirin 100 mg once daily) to include patients following recent lower-extremity revascularization (LER) due to symptomatic PAD.

The approval is based on data from the Phase III VOYAGER PAD study.

With this approval, Xarelto is the first and only therapy indicated to help reduce the risks of major cardiovascular (CV) events in patients with coronary artery disease (CAD) and major thrombotic vascular events, such as myocardial infarction, ischemic stroke, acute limb ischemia, and major amputation of a vascular etiology, in patients with PAD, including patients who have recently undergone LER due to symptomatic PAD.

Condition: Peripheral Artery Disease
Type: drug

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