FDA Approves Bayer's Sunharbo to Reduce Stroke Risk After Ischemic Events

The Food and Drug Administration (FDA) approved Bayer’s Sunharbo (asundexian) on Monday, Nov. 9, for use with antiplatelet therapy to reduce stroke risk in adults after a recent mild-to-moderate non-cardioembolic ischemic stroke or a high-risk transient ischemic attack (TIA). Sunharbo is the first Factor XIa inhibitor approved in the United States.

In the 12,327-person Phase 3 OCEANIC-STROKE trial, a once-daily 50-milligram dose reduced ischemic stroke risk by 26% compared with placebo over a median treatment period of 14.2 months. Participants in both groups also received antiplatelet therapy.

Major bleeding rates were similar overall but increased with Sunharbo among patients older than 75 and during the first 90 days of treatment. Gastrointestinal bleeding was more common, and diarrhea was the most frequently reported adverse reaction.