Abdul Mannan – Breaking in Haem: Andexanet Alfa Withdrawn from US Market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“Breaking in Haem: Andexanet Alfa Withdrawn from US Market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.”
More posts featuring Abdul Mannan on Hemostasis Today.
-
Jun 27, 2026, 01:31Alessio De Rose: Addressing Micronutrient Deficiencies in the Era of GLP-1 Receptor Agonists
-
Jun 27, 2026, 01:21Michelle Sámano Sánchez: Exploring Vitamin C as an Adjunct Therapy for Anemia in Hemodialysis
-
Jun 27, 2026, 01:08Ana Raquel Gotine: The First Pragmatic Clinical Trial on MNPs and Childhood Anemia in Mozambique
-
Jun 27, 2026, 00:56Sherif Badawy: Reflecting on My Time with ASH CRTI
-
Jun 27, 2026, 00:48Zain Khalpey: Why High quality CPR is Only Part of Successful Cardiac Arrest Management
-
Jun 26, 2026, 22:31Wendy Dusenbury: The New Issue of the Stroke Clinician is Now Live
-
Jun 26, 2026, 20:42Ed Watson: When It Happens to You, Stroke Becomes Personal, Immediate, and Life-Changing
-
Jun 26, 2026, 19:45Nathan Connell: Transforming Surgical Care with Tranexamic Acid
-
Jun 26, 2026, 18:28Daniel Pereira Monteiro: Why Is Beta Thalassaemia Major so Severe?