Andexanet alfa (Ondexxya) currently holds UK marketing authorisation (MA) for adult patients treated with a direct factor Xa (FXa) inhibitor (apixaban or rivaroxaban) when reversal of anticoagulation is indicated for life-threatening or uncontrolled bleeding, In National Health Service (NHS) Scotland, andexanet alfa is reimbursed for bleeding at any site,while in the rest of the United Kingdom, the National Institute of Health and Care Excellence (NICE) made recommendation in 2021 for its use in gastrointestinal bleeding only. The summary of product characteristics states that serious arterial and venous thromboembolic events have been reported following treatment with andexanet alfa, including reports of early manifestation (within 72 h) after administration...
The United States Food and Drug Administration (FDA) recently announced that, effective from 22 December 2025, AstraZeneca would withdraw andexanet alfa from manufacture and sale in the United Sates. This decision followed an unfavourable review of a supplemental Biologics Licensing Application to the FDA, which stated that: "based on available data, the serious risks including the increase in thromboembolic events are such that the FDA considers the risks of the product to outweigh its benefits."
In April 2025, the European Medicines Agency (EMA) reported that its Committee for Medicinal Products for Human Use (CHMP): "… having reviewed the available information on the status of the fulfilment of Specific Obligations and having confirmed the positive benefit risk balance, is of the opinion that the quality, safety and efficacy of this medicinal product continue to be adequately and sufficiently demonstrated and therefore recommends the renewal of the conditional MA for Ondexxya…"
Declaration of Interests
R.J.B. was a named investigator on an externally sponsored grant to HaemSTAR from AstraZeneca investigating the real-world use of reversal agents, including andexanet alfa. No personal payments were received from AstraZeneca. R.J.B. has also received consulting fees from Takeda, Sobi and Pfizer; speaker fees from Bayer, Takeda and Viatris; and research funding from Viatris and Sobi. C.A.B. has received honoraria and educational and/or research support from Amgen, Bayer, Bristol Myers Squibb/Pfizer Alliance, CSL, Janssen, Lilly, Novartis, Sanofi and Sobi. N.C. has received consulting fees from Octapharma, Hem-Ab, CSL Behring and Sobi and research funding from Octapharma and Sobi. D.J.S. has received honoraria from Sobi. M.R.T. has received honoraria and educational and/or research support from Ablynx, Anthos Therapeutics, Sanofi Genzyme and Bayer. K.B. has received honoraria from Bayer. D.J.A., C.N.B., G.B., B.J.H. and J.P.W. report no relevant conflicts of interest.