Janssen has submitted a supplemental new drug application to the US Food and Drug Administration (FDA) for two new Xarelto (rivaroxaban) vascular indications: reducing the risk of major cardiovascular (CV) events such as CV death, heart attack or stroke in patients with chronic coronary and/or peripheral artery disease (CAD/PAD), and for reducing the risk of acute limb ischaemia in patients with PAD.
This application is based on data from the landmark COMPASS study, the only randomised trial to investigate a Factor Xa inhibitor for preventing major CV events in this population.
Both CAD and PAD occur when arteries become hardened or narrowed due to a build up of cholesterol and plaque, limiting blood flow to parts of the body. While long-term aspirin use helps prevent CV events, it is only modestly effective and, despite use of preventative medicines as directed by current guidelines, an underlying thrombotic risk remains and people with CAD or PAD could still have a serious or fatal CV event.
“CAD and PAD impact millions of Americans and can lead to heart attack, stroke, and death. At Janssen, we want to help prevent the potentially devastating and irreversible harm associated with CV events that often occur in these patients,” said James F List, Global Therapeutic Area Head, Cardiovascular & Metabolism, Janssen. “Based on the results of COMPASS, we believe the combination of the vascular dose of Xarelto (2.5mg twice daily) plus aspirin can provide important benefits and potentially change the way physicians treat patients with CAD and PAD, if approved.”