Janssen has submitted a supplemental new drug application to the US FDA for two new indications for rivaroxaban (Xarelto, which is marketed by Bayer in Europe): reducing the risk of major cardiovascular events such as cardiac death, myocardial infarction or stroke in patients with coronary artery disease and/or peripheral arterial disease; and for reducing the risk of acute limb ischaemia in patients with peripheral arterial disease
This application is based on data from the COMPASS study, the only randomised trial to investigate a Factor Xa inhibitor (such as rivaroxaban) for preventing major cardiovascular events in this population.
While long-term aspirin use helps prevent cardiovascular events, a press release reports, it is only modestly effective. Also, despite use of preventative medicines as directed by current guidelines, an underlying thrombotic risk remains and people with coronary artery disease or peripheral arterial disease could still have a serious or fatal cardiovascular event.
James F List, Global Therapeutic Area Head, Cardiovascular & Metabolism, Janssen, says: “Coronary artery disease and peripheral arterial disease 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. 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 coronary artery disease and peripheral arterial disease, if approved.”