News

Prophylaxe gefährlicher Thrombosen revolutionieren

Studies demonstrate superior efficacy of Xarelto against a comparator

Bayer employees Dr. Susanne Röhrig and Dr. Alexander Straub, two of the inventors of Xarelto® from Medical Chemistry, observe crystals of new test compounds under the microscope.

Zoom image

Bayer employees Dr. Susanne Röhrig and Dr. Alexander Straub, two of the inventors of Xarelto® from Medical Chemistry, observe crystals of new test compounds under the microscope.

Bayer’s Xarelto® (active ingredient: rivaroxaban) has demonstrated superior efficacy against a comparator in the prevention of venous thromboembolism following hip or knee-joint replacement surgery. These were the findings of the overall evaluation of four Phase III studies in which this first Factor Xa inhibitor that can be taken in tablet form was thoroughly investigated. Says Professor A.G.G. Turpie from McMaster University in Canada, who is the lead investigator for the study program: “All reported findings confirm my confidence in Xarelto’s potential to revolutionize the prophylaxis of dangerous thromboses.”

An advisory committee to the U.S. Food and Drug Administration (FDA) also confirmed a favorable benefit-risk profile of rivaroxaban in venous blood clot prevention following hip or knee-joint replacement surgery. Although the advisory committee’s recommendation is not binding, the FDA will take its opinion into account when processing the registration application for rivaroxaban.

In addition, rivaroxaban showed encouraging results in patients with acute coronary syndrome (ACS). A Phase II study designed to test the anticoagulant in secondary prevention of ACS was successful. Rivaroxaban has now been transferred to the next development stage for this indication.