FDA Approves Expanded Indication for Xarelto

Xarelto is now indicated to help reduce the risks of major cardiovascular events in patients with coronary artery disease and major thrombotic vascular events.

The FDA has approved an expanded peripheral artery disease indication for the Janssen’s Xarelto (rivaroxaban) vascular dose (2.5 mg twice daily plus aspirin 100 mg once daily) to include patients following recent lower-extremity revascularization.

With this approval, Xarelto is the first therapy indicated to help reduce the risks of major cardiovascular events in patients with coronary artery disease and major thrombotic vascular events, such as myocardial infarction, ischemic stroke, acute limb ischemia, and major amputation of a vascular etiology, in patients with peripheral artery disease.

Peripheral artery disease is a chronic circulatory condition that causes blood vessels to narrow, reducing blood flow to the limbs, most often the legs. It is a disease which often goes undiagnosed and undertreated. In fact, an estimated 20 million Americans are living with the disease, but only 8.5 million are currently diagnosed. It is the leading cause of amputations in the United States.

Xarelto now has nine indications.

This is approval is based on the phase 3 VOYAGER PAD trial, which demonstrated that Xarelto vascular dose (2.5 mg twice daily plus aspirin 100 mg once daily) reduced the risk of major adverse limb and cardiovascular events by 15% in patients with symptomatic peripheral artery disease post- lower-extremity revascularization compared with aspirin alone.

The study included 6,564 patients from 542 sites across 34 countries worldwide; they were followed for a median of 28 months.

“PAD is a serious condition that is too frequently missed or often not even discussed by patients and their doctors due to lack of awareness and other health conditions that often take priority. It’s important to understand the risk factors for PAD, including conditions such as diabetes, smoking and high blood pressure,” Ryan Gough, executive director of the Partnership to Advance Cardiovascular Health, a heart patient advocacy organization, said in a statement. “There’s been a long-standing need across the healthcare community for increased education around PAD and better access to screening and innovative treatments. This is especially critical for patients in underserved communities, who are often at even greater risk for serious complications like amputation.”