Abdul Mannan – Breaking in Haem: Andexanet Alfa Withdrawn from US Market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“Breaking in Haem: Andexanet Alfa Withdrawn from US Market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.
-
Mar 18, 2026, 16:34Richard Buka: Exploring the COBRRA Trial in the Latest Episode of Don’t Just Read the Abstract
-
Mar 18, 2026, 16:22Heghine Khachatryan: Navigating the New Era of Hemophilia Gene Therapy
-
Mar 18, 2026, 16:21Georges Chahoud: Top Take-Home Messages from the AHA/ACC/Multisociety Acute PE Guideline
-
Mar 18, 2026, 16:19Cedric Hermans: Unleashing the Potential of Physical Activity in Hemophilia A Patients
-
Mar 18, 2026, 16:17Asif Mushtaq: Managing Cardiac Surgery with Cardiopulmonary Bypass in Hemophilia
-
Mar 18, 2026, 16:15Amir Kraitzer: Engineering Hemocompatible Surfaces to Overcome Thrombosis in Medical Devices
-
Mar 18, 2026, 16:11Hemant Sharma: Advancing Neonatal Care with New Strategies to Prevent IVH
-
Mar 18, 2026, 16:09Yves Bikorimana: How a Simple Temperature Change Can Trigger Antibody-Mediated Destruction of RBCs
-
Mar 18, 2026, 16:07Scott Isaacs: Optimizing Brain Vitality and Slowing Neurodegeneration Through Daily Habits