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Bayer: vascular Xarelto combo wins EU approval

(CercleFinance.com) - German pharma giant Bayer said on Friday that the European Commission has approved a combination based on its oral anticoagulant Xarelto for people with coronary or peripheral artery disease.


The European Commission has approved a regimen of Xarelto - taken twice daily - plus acetylsalicylic acid for the prevention of atherothrombotic events in adult patients with coronary artery disease or symptomatic peripheral artery disease at high risk for ischemic events.

The approval is based on data from a Phase III study, which showed that the combo reduced the risk of the composite of stroke, cardiovascular death and heart attack by 24% compared with acetylsalicylic acid taken once daily alone.

Bayer said that Germany is the first country where Xarelto is planned to be marketed for this indication.

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