trending Market Intelligence /marketintelligence/en/news-insights/trending/qOCfxy1dJmJ0-HxwGYJhsQ2 content esgSubNav
In This List

J&J, Bayer submit US FDA application for extended use of heart drug Xarelto

Blog

Shore Capital is Now Available in S&P Global’s Aftermarket Research Collection

Video

S&P Capital IQ Pro | Powered by Advanced Visualization

Video

S&P Capital IQ Pro | Unrivaled Sector Coverage

Video

S&P Capital IQ Pro | Powering Your Edge


J&J, Bayer submit US FDA application for extended use of heart drug Xarelto

Johnson & Johnson and development partner Bayer AG submitted an application to the U.S. Food and Drug Administration seeking two new indications for its heart drug Xarelto.

J&J unit Janssen Research & Development LLC and Bayer are seeking approval for Xarelto, or rivaroxaban, for reducing the risk of major cardiovascular events, including death, heart attack or stroke in patients with chronic coronary and peripheral artery disease and for reducing the risk of acute limb ischemia in patients with peripheral artery disease.

The companies are seeking approval based on results from the COMPASS study, which showed that Xarelto vascular dose of 2.5 milligram twice daily in combination with aspirin 100 mg once daily significantly reduced the risk of cardiovascular event death, or stroke by 24% in patients with chronic coronary and peripheral artery disease, compared to aspirin alone.

The trial was stopped about a year early due to efficacy.