FDA Approves Sunharbo Pill To Cut Risk Of Repeat Ischemic Strokes
The Food and Drug Administration has approved Sunharbo, a once-daily pill also known as asundexian, to reduce the risk of another ischemic stroke in adults who recently had a non-cardioembolic stroke or high-risk transient ischemic attack, giving stroke survivors in the US a new preventive option.[1]
The approval is based on a phase 3 trial of 12,327 patients in which adding Sunharbo to standard antiplatelet therapy cut repeat ischemic strokes by 26% compared with antiplatelet drugs plus a placebo over a median 14.2 months of follow-up, with stroke occurring in 6.6% of patients on the drug versus 8.8% on placebo. In the same study, the combined rate of cardiovascular death, heart attack, or stroke was 9.2% among people taking Sunharbo, compared with 11.1% for those on placebo, though patients on the drug experienced more gastrointestinal bleeding and higher rates of early major bleeding in those older than 75, prompting regulators and clinicians to flag bleeding risk as a key safety consideration.[1]
Trial results underpinning the decision were published Monday, November 9, in the New England Journal of Medicine and focused on patients whose strokes were not caused by heart rhythm problems like atrial fibrillation, a group that historically has had fewer effective options beyond antiplatelet drugs such as aspirin or clopidogrel to prevent recurrence. Researchers followed participants for a little over a year on average, so long-term safety and durability of benefit beyond roughly 14 months remain uncertain and will be tracked in post-approval monitoring and likely additional studies.
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📌 Key Facts
- FDA has approved Sunharbo (asundexian) to reduce recurrent stroke risk in adults with recent non-cardioembolic ischemic stroke or high-risk TIA.
- In a 12,327-patient phase 3 trial with 14.2 months median follow-up, asundexian plus antiplatelet therapy cut ischemic strokes by 26% relative to placebo plus antiplatelet therapy (6.6% vs. 8.8%).
- Cardiovascular death, heart attack or stroke occurred in 9.2% of asundexian patients versus 11.1% on placebo, while GI bleeding and early major bleeding in patients over 75 were increased with the drug.
- Trial findings were published Nov. 9 in the New England Journal of Medicine; long-term safety and efficacy beyond roughly 14 months are not yet known.
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