U.S. FDA Approves XARELTO® (rivaroxaban) to Reduce the Risk of Major Cardiovascular Events in Patients with Chronic Coronary Artery Disease (CAD) or Peripheral Artery Disease (PAD): Twice-daily XARELTO® 2.5-mg vascular dose significantly reduced the risk of major cardiovascular (CV) events by 24%, when combined with aspirin

TITUSVILLE, N.J., Oct. 11, 2018 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. 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 people with chronic coronary or peripheral artery disease (CAD/PAD). XARELTO^® is now the first and only Factor Xa inhibitor approved for patients living with these conditions.

Click to Tweet: New treatment option now approved for people with chronic #CAD or #PAD at risk of CV death, myocardial infarction or stroke https://ctt.ac/KB902+

This new indication is based on results from the landmark COMPASS trial, which showed a significant 24% reduction of the risk of major CV events in patients with chronic CAD and/or PAD with the XARELTO^® 2.5-mg vascular dose twice daily plus aspirin 100 mg once daily, compared to aspirin alone. This finding was driven by a 42% reduction in stroke, 22% reduction in CV death and 14% reduction in heart attack. The risk of major bleeding was significantly higher in patients taking the XARELTO^®/aspirin regimen compared to aspirin alone, with no significant increase in fatal or intracranial bleeds.

"Despite the use of guideline-recommended therapies, patients with chronic CAD and/or PAD remain at risk of having a devastating and irreversible CV event," said Paul Burton, MD, PhD, FACC, Vice President, Medical Affairs, Internal Medicine, Janssen Scientific Affairs, LLC. "The new XARELTO^® vascular 2.5-mg dose, when used with aspirin, represents a true breakthrough for patients with chronic CAD and PAD."

Click to Tweet: Janssen's blood thinner is now the first and only Factor Xa inhibitor with FDA approval to help reduce the risk of major CV events in people with chronic #CAD or #PAD https://ctt.ac/n2gD6+ 

"Treating patients with aspirin only is simply not enough to address the underlying thrombotic risk that comes with chronic CAD and PAD," said Kelley Branchⁱ, MD, MSc, FACC, FSCCT, Associate Professor in Cardiology, University of Washington, Seattle. "As we saw in the COMPASS trial, the dual pathway approach of aspirin and the 2.5-mg, twice-daily dose of XARELTO^® can help significantly reduce the risk of CV events in these populations."

Both chronic CAD...