Bayer's Asundexian Approved in China to Reduce Stroke Risk After Ischemic Stroke or High-Risk TIA

Bayer's oral FXIa inhibitor Asundexian has been approved in China through the priority review pathway to reduce stroke risk in adults after ischemic stroke or high-risk transient ischemic attack (TIA). The indication excludes patients with cardioembolic stroke, and the approval is based primarily on results of the global Phase III OCEANIC-STROKE trial. The drug targets activated factor XI (FXIa) to reduce pathological thrombus formation.