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Review
. 2018 Jul;78(10):1049-1055.
doi: 10.1007/s40265-018-0940-4.

Andexanet Alfa: First Global Approval

Young-A Heo  1
Affiliations
Review

Andexanet Alfa: First Global Approval

Young-A Heo. Drugs. 2018 Jul.

Erratum in

Abstract

Intravenous andexanet alfa [coagulation factor Xa (recombinant), inactivated-zhzo; Andexxa®] is a first-in-class recombinant modified factor Xa protein that has been developed by Portola Pharmaceuticals as a universal antidote to reverse anticoagulant effects of direct or indirect factor Xa inhibitors. In May 2018, andexanet alfa received its first global approval in the USA for use in patients treated with rivaroxaban and apixaban, when reversal of anticoagulant effects is required in life-threatening or uncontrolled bleeding. Intravenous andexanet alfa is under regulatory review in the EU and is undergoing clinical development in Japan. This article summarizes the milestones in the development of andexanet alfa leading to this first global approval for reversing anticoagulation of rivaroxaban and apixaban in adults.

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Conflict of interest statement

Funding

The preparation of this review was not supported by any external funding.

Conflict of interest

During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the author on the basis of scientific completeness and accuracy. Young-A Heo is a salaried employee of Adis/Springer, is responsible for the article content and declares no relevant conflicts of interest.

Figures

None
Key milestones in the development of andexanet alfa as a reversal agent for rivaroxaban and apixaban in adults who experience a major bleeding event. BLA biologics license application, MAA marketing authorization application
See this image and copyright information in PMC

References

    1. US FDA. FDA approved betrixaban (Bevyxxa, Portola) for the prophylaxis of venous thromboembolism (VTE) in adult patients [media release]. 23 June 2017. http://www.fda.gov.
    1. Kaatz S, Bhansali H, Gibbs J, et al. Reversing factor Xa inhibitors—clinical utility of andexanet alfa. J Blood Med. 2017;8:141–149. doi: 10.2147/JBM.S121550. - DOI - PMC - PubMed
    1. Levy JH, Douketis J, Weitz JI. Reversal agents for non-vitamin K antagonist oral anticoagulants. Nat Rev Cardiol. 2018;15(5):273–281. doi: 10.1038/nrcardio.2017.223. - DOI - PubMed
    1. Ansell JE. Reversing the effect of oral anticoagulant drugs: established and newer options. Am J Cardiovasc Drugs. 2016;16(3):163–170. doi: 10.1007/s40256-016-0162-7. - DOI - PubMed
    1. Hu TY, Vaidya VR, Asirvatham SJ. Reversing anticoagulant effects of novel oral anticoagulants: role of ciraparantag, andexanet alfa, and idarucizumab. Vasc Health Risk Manag. 2016;12:35–44. - PMC - PubMed

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