ESOC 2023 | Current opinions on andexanet alfa

Ashkan Shoamanesh, MD, McMaster University, Hamilton, Canada, discusses current opinions of andexanet alfa. Patients experiencing a hemorrhagic stroke while taking factor Xa (FXa) inhibitors such as apixaban, rivaroxaban, and edoxaban are at a higher risk of hematoma expansion and therefore, there is a need to develop reversal treatments which will reduce hematoma growth and improve outcomes of patients. In Europe (EU) and the United States (US), there is a direct FXa reversal agent called andexanet alfa which binds FXa inhibitors, enabling endogenous FXa to engage in the hemostatic cascade. A single arm trial called the ANNEXA-4 trial (NCT02329327), undertaken in patients mainly suffering from intracerebral hemorrhage, demonstrated that the degree of hemostatic efficacy was greater in this group compared to historical controls. However, as the study had no control arm it could not be determined if this was a treatment effect. Based on the results of this study, the EU and US regulators have approved andexanet alfa for use in patients with FXa-related intracerebral hemorrhage, on the basis that a Phase III clinical trial would be undertaken for full approval. Thus, the Phase III ANNEXA-I trial (NCT03661528) was launched, comparing andexanet alfa to usual care. In June, the study was terminated early due to interim analyses demonstrating a high hemostatic efficacy of andexanet alfa compared to standard care. Full study results have yet to be announced. This interview took place during the European Stroke Organisation Conference (ESOC) in Munich, Germany.

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