![]() These results are expected in the middle of 2015.Īndexanet alfa is currently being tested as an antidote to edoxaban (Savaysa, Daiichi Sankyo), the newest oral anticoagulant just approved by the US Food and Drug Administration, and the still-unavailable betrixaban (Portola Pharmaceuticals). In the second part of the ANNEXA-R study, investigators are testing the safety and effectiveness of andexanet alfa administered as an intravenous bolus followed by a continuous infusion of 8 mg/min for 120 minutes. The antidote has already been shown to successfully reverse the anticoagulation activity of apixaban (Eliquis, Bristol-Myers Squibb/Pfizer). The full results of the study, known as ANNEXA-R, are scheduled for presentation on Monday, Maat the American College of Cardiology 2015 Scientific Sessions in San Diego, CA, as part of an oral session highlighting original research. In the trial, an 800-mg intravenous bolus of andexanet alfa, which was tested in 41 healthy volunteers treated with rivaroxaban 20 mg for 4 days and then subsequently randomized to the study drug or placebo, "immediately and significantly" reversed the steady-state anticoagulation activity of rivaroxaban. SAN FRANCISCO, CA - Portola Pharmaceuticals, the makers of an antidote for rivaroxaban (Xarelto, Bayer Pharma/Janssen Pharmaceuticals), a factor Xa inhibitor that is part of the newest generation of oral anticoagulants, announced today that a phase 3 study testing the safety and efficacy of the antidote met its primary end point. Antidote Reverses Anticoagulation Activity of Rivaroxaban: ANNEXA-R
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