Drugs and FDA
FDA approves Bayer’s Sunharbo to reduce recurrent stroke risk
Sunharbo is approved with antiplatelet therapy for adults after a recent qualifying stroke or high-risk TIA.
The FDA approved Bayer’s Sunharbo (asundexian), the first factor XIa inhibitor, to reduce stroke risk in adults after a recent mild-to-moderate non-cardioembolic ischemic stroke or a high-risk transient ischemic attack. It is to be used with antiplatelet therapy.
In the phase 3 OCEANIC-STROKE study, 12,327 adults received Sunharbo or placebo alongside antiplatelet therapy. Over a median treatment of 14.2 months, Sunharbo 50 mg once daily reduced ischemic stroke risk by 26% compared with placebo, the FDA said. Gastrointestinal bleeding occurred more often, and diarrhea was the most frequently reported adverse reaction.
Bayer said the drug is expected to begin shipping in mid-to-late November.
Reporting on this story
- MedCity News FDA Approves First-in-Class Bayer Drug for Reducing the Risk of Stroke (opens in a new tab)
- MedPage Today Next-Gen Anticoagulant Lands FDA Nod for Secondary Stroke Prevention (opens in a new tab)
- Healio FDA approves Sunharbo, factor XIa inhibitor for reducing stroke (opens in a new tab)
