Reza Shojaei: FDA Approval Marks Milestone for Factor XIa-Targeted Therapy
Reza Shojaei, Chief Operating Officer at Canadian Plasma Resources, shared a post on LinkedIn:
“A new target in blood clotting. A new chapter in stroke prevention.
On November 9, the FDA approved Sunharbo (asundexian), its first Factor XIa inhibitor.
For those following coagulation science, this is a milestone worth watching.
Who is it for?
Adults after a recent mild-to-moderate non-cardioembolic ischemic stroke, where the clot did not originate in the heart, or a high-risk transient ischemic attack (TIA).
It is used alongside antiplatelet therapy.
What did the evidence show?
In OCEANIC-STROKE, involving 12,327 adults, asundexian reduced ischemic stroke risk by 26 percent relative to placebo.
Both groups received antiplatelet therapy.
The bleeding findings deserve equal attention:
Major bleeding rates were similar overall, but the FDA reported increased major bleeding with Sunharbo in patients older than 75 and during the first 90 days.
Gastrointestinal bleeding was also more common.
It is not approved for stroke prevention in atrial fibrillation.
My takeaway: this approval gives coagulation science a new clinical foothold and makes patient selection central to the conversation.
What will matter most as this reaches clinical practice: patient selection, bleeding surveillance, or access?
Read the FDA announcement.”
Stay in touch with the latest news in the field of hematology with Hemostasis Today.
-
Nov 11, 2026, 15:42Tareq Abadl: The Clinical Impact of Kell Alloimmunization
-
Nov 11, 2026, 15:30Alejandro González Veliz: Does PCI Change The Long-Term Outcome In Stable Coronary Artery Disease?
-
Nov 11, 2026, 15:25Preparing for the SoHO Regulation – EBA Board Convenes in Vienna – European Blood Alliance
-
Nov 11, 2026, 15:20Vaidehi Prasanth: IV Iron in Heart Failure – Exploring Hospitalisation Benefits vs. Infection Risk in Open Heart
-
Nov 11, 2026, 15:18Stefan Prendić: Can Algorithms Support Antibody Identification in Immunohematology?
-
Nov 11, 2026, 15:12Perioperative Challenges in Hemophilia Patients on Rebalancing Therapies
-
Nov 11, 2026, 15:03Maria Elisa Mancuso: World-Renowned Faculty and 33 Global Participants Unite at Hemophilia Academy 2026
-
Nov 11, 2026, 15:01Hassan Raza: The JAK2 V617F Revolution
-
Nov 11, 2026, 14:57Edward Lee Carter: Factor Xla Inhibition Enters Clinical Practice – FDA Approval of Asundexian