FDA Authorizes Novel Factor XIa Inhibitor for Recurrent Stroke Prevention

The FDA has approved asundexian (Sunharbo by Bayer), the first oral factor XIa inhibitor, for reducing recurrent stroke risk in adults following a noncardioembolic ischemic stroke or high-risk TIA. This approval introduces a new therapeutic class for secondary stroke prevention, to be used with antiplatelet therapy. The Phase 3 OCEANIC-STROKE trial showed a 26% reduction in ischemic stroke without a significant increase in major bleeding.