Andexanet alfa is available as a 100 mg vial for injection/infusion. 2.3) continued approval for this indication is contingent upon the demonstration of improved haemostasis in patients in post-marketing studies.
The approval was based on the change in anti-factor Xa activity from baseline in two phase III studies in healthy volunteers (Sect. On, andexanet alfa received US FDA accelerated approval for patients treated with rivaroxaban or apixaban who require reversal of the anticoagulant effects in life-threatening or uncontrolled bleeding. BLA biologics license application, MAA marketing authorization application Key milestones in the development of andexanet alfa as a reversal agent for rivaroxaban and apixaban in adults who experience a major bleeding event. Andexanet alfa acts as a decoy and binds to factor Xa inhibitors, neutralizing the anticoagulant effects of factor Xa inhibitors by preventing the inhibitors from binding to endogenous factor Xa. Intravenous andexanet alfa is a first-in-class recombinant modified factor Xa protein that has been developed by Portola Pharmaceuticals as a universal antidote to reverse the anticoagulant effects of direct or indirect factor Xa inhibitors. warfarin), the risk of bleeding complications still exists and the availability of a specific reversing agent would be beneficial. Although these agents show a better bleeding risk profile compared with that of vitamin K antagonists (e.g. fondaparinux and the low-molecular-weight-heparin enoxaparin) factor Xa inhibitors are effective anticoagulants for the treatment and prevention of thromboembolism, and stroke prevention in atrial fibrillation.
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