Xarelto sNDA Submitted for Two New Vascular Indications
A supplemental New Drug Applications (sNDA) has been submitted to the Food and Drug Administration (FDA) for two new indications for Xarelto (rivaroxaban; Janssen): to reduce the risk of major cardiovascular (CV) events in patients with chronic coronary and/or peripheral artery disease (CAD/PAD), and to reduce the risk of acute limb ischemia in PAD patients.
The sNDA is based on results from the Phase 3 COMPASS study which included 27,395 patients with CAD and/or PAD. Participants were randomized 1:1:1 to receive either Xarelto 2.5mg twice daily plus aspirin 100mg once daily, Xarelto 5mg twice daily, or aspirin 100mg once daily.
The COMPASS study results found that the Xarelto/aspirin regimen reduced CV events by 24% compared to aspirin alone (CV events: 4.1% for Xarelto/aspirin vs. 5.4% for aspirin alone). For this group the risk of stroke was reduced by 42% (HR 0.58; 95% CI, 0.44–0.76; P<0.001), CV death by 22% (HR 0.78; 95% CI, 0.64–0.96; P=0.02) and heart attack by 14% (HR 0.86; 95% CI, 0.70–1.05; P=0.14).
“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,” said James F. List, MD, PhD, Global Therapeutic Head, Janssen.
For more information visit Janssen.com.