FDA Approves New Medication to Reduce Recurrent Stroke Risk

The FDA has approved Sunharbo (asundexian) to reduce the risks of a recurring stroke in some adults. The medication is taken as one 50 mg pill each day, along with standard blood clot-preventing medicine, such as aspirin. It is designed to lower the risk of another stroke in adults who recently had a stroke caused by a blood clot (not a heart-related clot) or a mini-stroke (transient ischemic attack, or TIA) (1). [1]

Sunharbo is the first medication of its kind to block a specific protein in the blood (factor XIa) that helps blood clots form. Approval followed a Phase 3 randomized trial involving 12,327 patients across 37 countries, all of whom had a recent non-cardioembolic ischemic stroke or high-risk TIA. Among those who took 50 mg of asundexian orally once daily, plus antiplatelet therapy for a period of 14.2 months, there was a 26% relative reduction in ischemic stroke compared to groups who took a placebo along with antiplatelet therapy (1). [1]

Although there was not a significant overall increase in major bleeding, the risk of that side effect was higher in certain subgroups. However, gastrointestinal bleeding was more common with asundexian, and major bleeding was increased among patients older than 75 during the first 90 days. The findings were published in The New England Journal of Medicine Nov. 9 (1). [1]

The trial, which was funded by Bayer, the manufacturer of asundexian, had several limitations. Because patients were treated for an average of about 14 months, long-term safety and effectiveness of the medication are unclear. The study also excluded patients with certain heart conditions and those with more severe strokes (1). [1]

The FDA has approved Sunharbo (asundexian) to reduce the risks of a recurring stroke in some adults. The medication is taken as one 50 mg pill each day, along with standard blood clot-preventing medicine, such as aspirin. It is designed to lower the risk of another stroke in adults who recently had a stroke caused by a blood clot (not a heart-related clot) or a mini-stroke (transient ischemic attack, or TIA), according to the FDA release (source ID: 1). [1]

Sunharbo is the first medication of its kind to block a specific protein in the blood (factor XIa) that helps blood clots form. Approval followed a Phase 3 randomized trial involving 12,327 patients across 37 countries, all of whom had a recent non-cardioembolic ischemic stroke or high-risk TIA. Among those who took 50 mg of asundexian orally once daily, plus antiplatelet therapy for a period of 14.2 months, there was a 26% relative reduction in ischemic stroke compared to groups who took a placebo along with antiplatelet therapy (source ID: 1). [1]

Although there was not a significant overall increase in major bleeding, the risk of that side effect was higher in certain subgroups. However, gastrointestinal bleeding was more common with asundexian, and major bleeding was increased among patients older than 75 during the first 90 days. Patients who took asundexian also had a lower risk of stroke, heart attack or death compared with those who received a placebo (source ID: 1). [1]

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