Portola Pharmaceuticals is the developer of Andexxa® [coagulation factor Xa (recombinant), inactivated-zhzo], the first and only antidote designed for patients undergoing treatment with rivaroxaban and apixaban, in cases where reversal of anticoagulation is necessary due to severe or uncontrollable bleeding.
The swift reversal of the anticoagulant effects of rivaroxaban and apixaban by Andexxa enables healthcare professionals to effectively address life-threatening hemorrhages, where time is of the essence.
The utilization of factor Xa inhibitors is rapidly increasing due to their proven effectiveness and safety compared to enoxaparin and warfarin for the prevention and treatment of thromboembolic conditions such as stroke, pulmonary embolism, and venous thromboembolism (VTE).
Andexxa stands as a pioneering medication with the potential to save lives and make a substantial impact on global public health.
Andexxa has obtained approval from the U.S. Food and Drug Administration (FDA). The approval of Andexxa is based on data derived from two Phase 3 ANNEXA studies (ANNEXA-R and ANNEXA-A) published in The New England Journal of Medicine. These studies examined the safety and efficacy of Andexxa in reversing the anticoagulant activity of the Factor Xa inhibitors rivaroxaban and apixaban in healthy volunteers.
Andexxa swiftly and significantly reverses anti-Factor Xa activity, which constitutes the anticoagulant mechanism of these medications.
The median reduction in anti-Factor Xa activity from the initial level was 97 percent for rivaroxaban and 92 percent for apixaban.
The data collected from 185 eligible patients demonstrated that Andexxa promptly and markedly reversed anti-Factor Xa activity when administered as a bolus and maintained this reversal when followed by a 120-minute infusion. The median decrease from the initial level was 90 percent for rivaroxaban and 93 percent for apixaban.
A post-marketing requirement entails conducting a clinical trial where patients are randomly assigned to receive either Andexxa or standard care (the type of care provided by the enrolling institution in the absence of Andexxa).
