FDA Approves First-in-Class Drug Asundexian for Stroke Prevention

The FDA has approved asundexian (Sunharbo), a novel factor XIa inhibitor, for reducing recurrent stroke risk in adults who recently experienced an ischemic stroke or high-risk TIA. This marks the first FXIa inhibitor approved for this indication. Clinical trials showed that once-daily asundexian, combined with antiplatelet therapy, reduced ischemic stroke risk by 26% compared to placebo.