FDA Approves New Factor XIa Inhibitor Asundexian for Secondary Stroke Prevention

The U.S. Food and Drug Administration (FDA) has approved asundexian, the first factor XIa inhibitor, to reduce the risk of recurrent stroke in adults following a noncardioembolic ischemic stroke or high-risk transient ischemic attack (TIA). Marketed as Sunharbo, the therapy is intended for use in combination with antiplatelet therapy, based on positive phase 3 OCEANIC-STROKE data.