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Reported Earlier, Bayer’s SUNHARBO Receives FDA Approval As First Factor XIa Inhibitor, Reducing Ischemic Stroke 6.2% Versus 8.4% For Placebo In 12,327-Patient Phase 3 OCEANIC-STROKE Study

Benzinga·11/10/2026 06:52:29
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  • The full indication for SUNHARBO (asundexian) is to reduce the risk of stroke in adults with recent non-cardioembolic ischemic stroke (National Institutes of Health Stroke Scale [NIHSS] ≤15) or high-risk transient ischemic attack (TIA) in combination with antiplatelet therapy.1
  • SUNHARBO is a first-in-class, once daily, Factor XIa inhibitor for secondary stroke prevention.1
  • Approximately one in five people who had a stroke will have another stroke within five years, and secondary strokes often cause more devastating outcomes than first strokes.2