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October 11, 2018

FDA Approves Indication for Xarelto to Reduce Risk of Major CV Events in Patients With Chronic CAD or PAD

October 11, 2018—The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the FDA has approved Xarelto (rivaroxaban) to reduce the risk of major cardiovascular (CV) events, such as CV death, myocardial infarction, and stroke, in those with chronic coronary or peripheral artery disease (CAD/PAD). Xarelto is a factor Xa inhibitor.

According to the company, approval of this new indication is based on results from the landmark, phase 3 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 included 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.

The COMPASS clinical study was composed of 27,395 patients with chronic CAD or PAD from 33 countries to examine the use of Xarelto, alone or in combination with aspirin, for the long-term prevention of major adverse CV events, including heart attack, stroke and CV death.

In February 2017, COMPASS was stopped approximately 1 year ahead of schedule because the trial met its primary endpoint of efficacy. The results were presented in August 2017 at the European Society of Cardiology's ESC Congress in Barcelona, Spain and simultaneously published by John W. Eikelboom, MBBS, et al in The New England Journal of Medicine (2017;377:1319–1330).

Two subanalyses from COMPASS were conducted in patients with PAD and CAD. The PAD study was published by Prof. Stuart J Connolly, MD, et al in The Lancet (2018;391:205–218). The CAD study was published by Prof. Sonia S. Anand, MD, et al in The Lancet (2018;391:219–229).

In the company's press release, Kelley Branch, MD, commented, "Treating patients with aspirin only is simply not enough to address the underlying thrombotic risk that comes with chronic CAD and PAD. 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." Dr. Branch is Associate Professor in Cardiology at the University of Washington in Seattle, Washington.

In July 2018, Janssen's development partner Bayer announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency granted a positive opinion to update the Xarelto label to include the new vascular indication in the European Union. On August 24, the European Commission granted approval, advised Janssen.

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