The United States has cleared Bayer's Sunharbo (asundexian), making it the first Factor XIa inhibitor to receive U.S. approval for lowering stroke risk after a recent ischemic stroke or high-risk TIA.
The U.S. Food and Drug Administration (FDA) approved the medicine Nov. 9 for adults after a recent ischemic stroke that was mild to moderate and not cardioembolic, or a high-risk transient ischemic attack (TIA). Treatment consists of 50 milligrams once a day, alongside antiplatelet therapy.
The 12,327-person Phase 3 OCEANIC-STROKE study compared asundexian with placebo, with antiplatelet treatment in each arm. At a median 14.2 months of treatment, the asundexian group had 26% lower ischemic stroke risk.
Major bleeding rates were similar across the trial, but higher among Sunharbo recipients older than 75 and during the treatment's first 90 days. Gastrointestinal bleeding occurred more often with Sunharbo, and diarrhea was the adverse reaction most frequently reported.
