FDA Clears New Anticoagulant Asundexian for Secondary Stroke Prevention

The U.S. FDA has approved asundexian (Sunharbo), a novel factor XIa inhibitor, for adults who have recently experienced a noncardioembolic ischemic stroke or a high-risk transient ischemic attack (TIA). This marks the first approval in this new class of oral anticoagulants. Clinical trials demonstrated that asundexian reduced ischemic stroke rates by 26% without increasing major bleeding risks, offering a new option for secondary stroke prevention.