The FDA approved asundexian (Sunharbo), the first factor XIa inhibitor, to reduce stroke risk after recent noncardioembolic ischemic stroke or high-risk TIA.
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The 50-mg tablet is taken once daily with antiplatelet therapy in eligible patients; the indication does not include stroke prevention in atrial fibrillation.
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In the phase 3 OCEANIC-STROKE trial of 12,327 adults, ischemic stroke occurred in 6.2% of asundexian recipients and 8.4% of placebo recipients.
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Major bleeding rates were similar overall, but were higher with asundexian among patients older than 75 years and during the first 90 days of treatment.
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The prescribing information advises against use with combined P-glycoprotein and strong CYP3A4 inducers or in moderate or severe hepatic impairment, and recommends withholding treatment around procedu
