December 23, 2025
1 min read
Key takeaways:
- AstraZeneca will no longer make and sell andexanet alfa in the U.S.
- The decision was based on results of postmarketing safety data that indicated increased thromboembolic risk from the drug vs. usual care.
AstraZeneca withdrew andexanet alfa, an antidote to several direct oral anticoagulants, from the U.S. market, ending U.S. commercial sales and manufacturing of the recombinant modified human factor Xa protein, the FDA announced.
The FDA determined risks of the product (Andexxa), including serious and fatal thromboembolic events, outweigh its benefits, and communicated its position to the manufacturer following a meeting of the Cellular, Tissue and Gene Therapies Advisory Committee in 2024, according to an agency safety communication.
As Healio previously reported, the FDA approved andexanet alfa in 2018 as the first antidote indicated for reversal of anticoagulation with rivaroxaban (Xarelto, Janssen/Bayer) and apixaban (Eliquis, Bristol Myers Squibb/Pfizer) in the setting of life-threatening or uncontrolled bleeding.
The approval was based on the results of the ANNEXA-4 trial in which andexanet alfa demonstrated similar safety and efficacy outcomes vs. other reversal agents.
However, subsequent postmarketing safety data received by the FDA indicated use of andexanet alfa was associated with increased incidence of thrombosis (14.6% vs. 6.9%) and thrombosis-related death (2.5% vs. 0.9%) at 30 days compared with usual care. Therefore, AstraZeneca halted U.S. manufacture and sale of andexanet alfa on Dec. 22, according to the FDA safety communication.
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