Posted by Michael Wonder on 07 Nov 2017
Bayer submits application for marketing approval of rivaroxaban for patients with coronary or peripheral artery disease to European Medicines Agency
6 November 2017 - The application for marketing approval is based on the COMPASS study.
Bayer has submitted an application to the EMA for the marketing authorisation of the vascular dose of its Factor Xa inhibitor rivaroxaban (Xarelto) in combination with aspirin for the treatment of patients with coronary artery disease (CAD) or peripheral artery disease (PAD).
The submission is based on results of the Phase III COMPASS study, which showed that the vascular dose of rivaroxaban (2.5 mg twice daily) plus aspirin 100 mg once daily reduced the risk of the composite outcome of stroke, cardiovascular (CV) death and heart attack by an unprecedented 24% (relative risk reduction) compared with aspirin 100 mg once daily alone in patients with CAD or PAD. A filing in the US is expected by the end of the year.
