Janssen submits supplemental New Drug Application to FDA seeking new indications for Xarelto (rivaroxaban) for patients with chronic coronary and/or peripheral artery disease (CAD/PAD).
Janssen Research & Development, LLC today announced it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for two new Xarelto (rivaroxaban) vascular indications: Reducing the risk of major cardiovascular events such as cardiovascular 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 ischemia in patients with PAD.
This application is based on data from the landmark COMPASS study, the only randomized trial to investigate a Factor Xa inhibitor for preventing major cardiovascular events in this population.
Both CAD and PAD occur when arteries become hardened or narrowed due to a buildup 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.i
“Based on the results of COMPASS, we believe the combination of the vascular dose of Xarelto (2.5 mg twice daily) plus aspirin can provide important benefits and potentially change the way physicians treat patients with CAD and PAD, if approved,” James F. List, M.D., Ph.D., Janssen’s global therapeutic area head, cardiovascular and metabolism, said.
i Bhatt DL, Eagle KA, Ohman EM, et al. Comparative determinants of 4-year cardiovascular event rates in stable outpatients at risk of or with atherothrombosis. JAMA 2010;304:1350-7.
(Source: Janssen Research & Development, LLC)
Filed Under: Drug Discovery