Janssen announced that the Food and Drug Administration (FDA) has approved Xarelto (rivaroxaban) to reduce the risk of major cardiovascular (CV) events, such as CV death, myocardial infarction (MI) and stroke, in patients with chronic coronary or peripheral artery disease (CAD/PAD). 

The FDA approval was supported by data from the Phase 3 COMPASS trial (N=27,395) which evaluated Xarelto with or without aspirin for the long-term prevention of major adverse CV events (including MI, stroke, CV death) in patients with chronic CAD or PAD. Results showed a 24% reduction in the risk of major CV events in patients with chronic CAD and/or PAD with Xarelto 2.5mg twice daily + aspirin 100mg once daily, compared with aspirin alone. Specifically, the data showed a 42% reduction in stroke, 22% reduction in CV death, and 14% reduction in MI. 

Patients in the Xarelto + aspirin treatment arm had a significantly higher risk of major bleeding vs the aspirin treatment arm. There was no significant increase, however, in fatal or intracranial bleeds. The sub-analyses of patients with CAD and PAD were published in The Lancet

“As we saw in the COMPASS trial, the dual pathway approach of aspirin and the 2.5mg, twice-daily dose of Xarelto can help significantly reduce the risk of CV events in these populations,” stated Kelley Branch, MD, MSc, FACC, FSCCT, Associate Professor in Cardiology, University of Washington, Seattle. 

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Xarelto, a factor Xa inhibitor, is already approved to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation; for the treatment of deep vein thrombosis (DVT), pulmonary embolism (PE); to reduce the risk of recurrence of DVT and/or PE in patients at continued risk for recurrent DVT and/or PE after completion of initial treatment lasting ≥6 months; and for prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery. It is available in 2.5mg, 10mg, 15mg, and 20mg strength tablets. 

For more information call (800) 526-7736 or visit Janssen.com.