Abdul Mannan – Breaking in Haem: Andexanet Alfa Withdrawn from US Market
Abdul Mannan, Consultant Haematologist at Betsi Cadwaladr University Health Board, shared on LinkedIn:
“Breaking in Haem: Andexanet Alfa Withdrawn from US Market
A major shift in anticoagulation reversal is happening. AstraZeneca is withdrawing the BLA for Andexxa (andexanet alfa), effective Dec 22, 2025.
Why is this happening? Let us make it simple
It’s a case of “Biochemistry vs. Clinical Outcome.”
We failed to bridge the gap from Accelerated Approval (2018) to Traditional Approval.
The Data Dilemma:
Efficacy: It worked. In ANNEXA-4, it slashed anti-Factor Xa activity (e.g., Apixaban levels dropped from ~150 to ~11 ng/mL).
Safety: The ANNEXA-I trial showed a worrying signal. Thrombotic events were 14.6% with Andexanet vs 6.9% with usual care (PCC).
What now?
We return to the basics. For life-threatening bleeding on apixaban or rivaroxaban, we rely on Prothrombin Complex Concentrates (PCC).
A reminder that even ‘targeted’ antidotes must prove they don’t cause more harm than the bleeding they are trying to stop.”
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