ISSUE1746
Andexanet alfa (Andexxa – AstraZeneca), which received accelerated approval from the FDA in 2018 for urgent reversal of the anticoagulant effect of the direct factor Xa inhibitors apixaban (Eliquis) and rivaroxaban (Xarelto), has voluntarily been withdrawn from the market.1 Andexxa was the only drug FDA-approved for this indication in the US.
Accelerated approval of andexanet alfa was based on its effect on anti-activated factor Xa activity, a surrogate endpoint.1 The drug improved hemostasis in a confirmatory trial in patients with severe intracranial bleeding, but it was associated with an increased rate of thrombosis. Based on these results, the FDA declined to grant Andexxa full approval.2
Alternatives to andexanet alfa for reversing factor Xa inhibitor activity include four-factor prothrombin complex concentrates (PCC; Kcentra, Balfaxar) and anti-inhibitor coagulant complex (FEIBA).
- Andexxa – an antidote for apixaban and rivaroxaban. Med Lett Drugs Ther 2018; 60:99.
- FDA Briefing Document. Andexxa (coagulation factor Xa (recombinant), inactivated-zhzo). Cellular, Tissue, and Gene Therapies Advisory Committee Meeting, November 21, 2024. Available at: https://bit.ly/4qjzCko. Accessed December 19, 2025.
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