December 12, 2017
Janssen Seeks New Indications for Xarelto for Patients With Chronic PAD or CAD
December 11, 2017—Janssen Research & Development, LLC announced that it has submitted a supplemental New Drug Application to the US Food and Drug Administration for two new vascular indications for Xarelto (rivaroxaban): reducing the risk of major cardiovascular (CV) events such as CV death, heart attack, or stroke in patients with chronic coronary and/or peripheral artery disease (CAD/PAD) and reducing the risk of acute limb ischemia in patients with PAD. This application is based on data from the landmark COMPASS study, a randomized trial that investigated this factor Xa inhibitor for preventing major CV events in this population.
According to the company, the COMPASS study showed that the Xarelto vascular dose of 2.5 mg twice daily plus aspirin 100 mg once daily significantly reduced the risk of major CV events defined as CV death, heart attack, or stroke by 24% in patients with chronic CAD and/or PAD compared to aspirin alone. This finding was driven by a 42% reduction in stroke and 22% reduction in CV death.
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.
COMPASS is a phase 3 clinical study of 27,395 patients with chronic CAD and/or PAD from 33 countries that examined the use of Xarelto alone or in combination with aspirin in the long-term prevention of major adverse CV events, including heart attack, stroke, or CV-related death. COMPASS is part of the EXPLORER program that is generating clinical evidence on the safety and efficacy of Xarelto and its potential role in addressing critical unmet medical needs. EXPLORER is a collaborative effort between Janssen and Bayer AG, which partnered in the development of Xarelto.
The company noted that COMPASS was stopped approximately 1 year ahead of schedule because of efficacy, and the results were presented in August during a Hot Line session at the European Society of Cardiology's ESC Congress 2017 in Barcelona, Spain and simultaneously published in The New England Journal of Medicine (2017;377:1319–1330).
In addition, two subanalyses from COMPASS in patients with PAD by Prof. Sofia S. Anand, MD, et al and in patients with CAD by Prof. Stuart J. Connelly, MD, et al were recently published in The Lancet.