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AstraZeneca Withdraws Andexxa From U.S. Market After FDA Says Risks Outweigh Benefits

A confirmatory trial submitted this year showed excess thrombotic events versus usual care.

AstraZeneca has pulled Andexxa, an emergency coagulant, from the US market following the FDA's request. Image credit: andreaaaaaaaaa via ShutterStock.com.
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Overview

  • AstraZeneca will halt U.S. manufacturing and commercial sales of Andexxa after December 22, 2025.
  • The FDA reviewed postmarketing data and concluded the drug’s safety risks outweigh its benefits due to serious and fatal thromboembolic events.
  • In the ANNEXA‑I trial, thrombosis occurred in 14.6% of patients on Andexxa versus 6.9% with usual care, with more thrombosis‑related deaths by Day 30 and earlier onset of events in the treatment arm.
  • Andexxa received accelerated approval in 2018 based on a surrogate endpoint and carried a boxed warning for thromboembolic risk, with a 2024 advisory committee meeting leaving full approval unresolved.
  • The therapy remains conditionally authorized by the EMA and UK MHRA, and it generated $219 million in global sales in 2024, including $81 million in the U.S.