German pharma major Bayer (BAYN: DE) has today (July 2) revealed results of an open-label, single-center, parallel-group Phase I study showing that three- and four-factor prothrombin complex concentrates (PCCs) can reverse the anticoagulant effect measured by coagulation assays in study participants treated with the oral anticoagulant Xarelto (rivaroxaban).
Oral anticoagulants such as Xarelto have been associated with excess bleeding in some instances, and the aim is to assuage doctors’ concerns about bleeding or sudden need for surgery, and the lack of an antidote to Xarelto. No agents are approved to reverse the activity of Factor Xa inhibitors.
“PCCs can be used to reverse the blood thinning effects of anticoagulants such as warfarin and are important in emergency situations involving uncontrolled bleeding,” said Marcel Levi, Professor of Medicine and Dean of Medicine at the Academic Medical Center of the University of Amsterdam, Netherlands, adding: “These data provide additional information on how to potentially reverse the anticoagulant effects of rivaroxaban.”
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