Abdul Mannan – Breaking in Haem: Andexanet Alfa Withdrawn from US Market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“Breaking in Haem: Andexanet Alfa Withdrawn from US Market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.
-
Nov 8, 2026, 19:31Anna Kajaste-Rudnitski: Presenting AAV-Induced p53 Signalling in Human CNS Cells at ESGCT 26
-
Nov 8, 2026, 19:29David McIntosh: Cybersecurity Matters, but Blood Availability Remains the Bigger Challenge
-
Nov 8, 2026, 19:26Wenxue Ma: An Integrative Framework for Macrophage-Mediated Therapeutic Resistance in Cancer
-
Nov 8, 2026, 19:25Yildiz Yigit: Presenting a Polycythemia Vera Case at the MPN Subcommittee Session
-
Nov 8, 2026, 18:56Denis Oduor: Strengthening the Regulation and Delivery of Blood Transfusion and Transplantation Services
-
Nov 8, 2026, 18:28Raghavendra Rao: A Narrative Review on Chronic Venous Disease during Pregnancy
-
Nov 8, 2026, 17:57Dhiren Patel: PLD1-Derived Phospholipids Regulate NAD Kinase and ROS Production in Neutrophils
-
Nov 8, 2026, 17:48Andra T.: What Causes Antiphospholipid Syndrome? – Four Steps, not One Cause
-
Nov 8, 2026, 17:38Nasrin Samadi: Can a Normal Clotting Test Be Misleading?