12/18/2023 0 Comments Andexxa availability![]() “The interim efficacy and safety data continue to support the promising role of AndexXa as an antidote to reverse anticoagulation in Factor Xa-associated bleeding.” ![]() Connolly, ANNEXA-4 Executive Committee chairman and professor in the Department of Medicine of the Faculty of Health Sciences at McMaster University in Hamilton, Ontario, Canada. “These data are particularly compelling when you consider the high-risk profile of the ANNEXA-4 population, which includes a substantial number of elderly patients presenting with intracranial haemorrhage and anticoagulated for venous thromboembolism, and the lack of any FDA- or EMA-approved reversal agent for these patients,” said Stuart J. Thrombotic events (11%) and death rates (12%) were consistent with previous ANNEXA-4 trial results and with the high background thrombotic risk of the enrolled patient population. In addition, 83% of these patients achieved excellent or good haemostasis (stoppage of bleeding) over a 12-hour period following treatment with AndexXa. Interim data from 228 patients (of which 132 were adjudicated for efficacy) showed that AndexXa rapidly and significantly reversed anti-Factor Xa activity (the anticoagulant mechanism of these drugs) when administered as a bolus, and sustained this reversal when followed by a 120-minute infusion.
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