Stroke survivors get FDA-approved daily pill shown to cut repeat risk by 26%

The US Food and Drug Administration has approved Sunharbo (asundexian), a once-daily pill to reduce the chance of another clot-related stroke in some adults. It is taken alongside standard antiplatelet treatment, such as aspirin, and works by blocking factor XIa, a protein involved in blood clotting.

Approval was based on a trial of 12,327 people in 37 countries, followed for an average of 14.2 months. Stroke occurred in 6.6% of participants taking asundexian and 8.8% taking a placebo, a 26% relative reduction; major bleeding did not rise significantly overall, though gastrointestinal bleeding was more common and major bleeding increased among patients over 75 in the first 90 days. The medicine is not intended for strokes linked to atrial fibrillation or heart valve problems, and longer-term safety and effectiveness remain uncertain.