Posted by Michael Wonder on 12 Dec 2017
Bayer’s rivaroxaban submitted to U.S. FDA for approval in patients with coronary and/or peripheral artery disease
11 December 2017 - The rivaroxaban vascular dose, 2.5 mg twice daily plus aspirin 100 mg once daily, demonstrated a 24% reduction in the combined risk of stroke, cardiovascular death and heart attack.
Bayer´s development partner, Janssen has submitted a supplemental new drug application to the U.S. FDA for the rivaroxaban (Xarelto) vascular dose, 2.5 mg twice daily, to be used in combination with low dose aspirin. The application requests approval of two new indications for the rivaroxaban vascular dose: for 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 for reducing the risk of acute limb ischaemia in patients with PAD.
This application is based on the Phase III COMPASS study.
