Bayer hopes to break into atherosclerosis setting with Xarelto filing
An application has been lodged with the European Medicines Agency to extend the label for Xarelto (rivaroxaban), in combination with aspirin, to treat coronary artery disease (CAD) or peripheral artery disease (PAD).
The submission for the Factor Xa inhibitor, sold by Germany’s Bayer (BAYN: DE), is supported by results of the Phase III COMPASS study, which was stopped at the start of the year based on the strength of the efficacy data.
Data from the study showed a 42% reduction in stroke and a 22% reduction in CV death, compared to aspirin alone.
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