Shekher Bose on AstraZeneca’s Voluntary Withdrawal of Andexxa
Shekher Bose, Client Partner at Beyondsight Intelligence, reposted Beyondsight Intelligence on LinkedIn:
”This marks the end of availability for the only specific reversal agent for apixaban and rivaroxaban in the U.S., shifting reliance back to non-specific options like PCCs or supportive care for managing FXa inhibitor-associated bleeds.”
Qutoing Beyondsight Intelligence‘s post:
”FDA Issues Safety Update on Andexxa — U.S. Withdrawal Announced
The FDA has determined that postmarketing safety data for Andexxa (andexanet alfa), the anticoagulation reversal agent, show that serious thromboembolic risks outweigh its clinical benefits.
AstraZeneca will voluntarily withdraw Andexxa from the U.S. market, with availability ending December 22, 2025.
Key Points:
• Granted accelerated approval in 2018 for reversal of rivaroxaban and apixaban in life-threatening or uncontrolled bleeding
• Approval included a Boxed Warning for thromboembolic risk
• Postmarketing evidence, including ANNEXA-I, raised concerns around thrombotic events and mortality
Why It Matters:
• Highlights how real-world and confirmatory data can fundamentally shift benefit–risk assessments
• Reinforces the FDA’s scrutiny of accelerated approvals when safety signals emerge
• Leaves a gap in anticoagulation reversal options, impacting critical care decision-making
Key Takeaway:
Andexxa’s U.S. withdrawal underscores the power of post-approval evidence in reshaping regulatory outcomes—and the importance of long-term safety surveillance for high-risk biologics.
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