The article examines the objective, findings, and clinical context described in FDA approves first factor XIa stroke drug.
Approach:
Approval: The FDA approved asundexian (Sunharbo), a 50-mg tablet taken once daily with antiplatelet therapy, for adults with a recent noncardioembolic ischemic stroke and NIH Stroke Scale score of 15 or lower, or a high-risk TIA. The indication does not include stroke p…
Trial: Approval was supported by OCEANIC-STROKE, a randomized, double-blind, placebo-controlled phase 3 trial of 12,327 adults. Participants began asundexian or placebo, each with antiplatelet therapy, within 72 hours of symptom onset.
Key Findings:
Ischemic stroke occurred in 6.2% of participants receiving asundexian and 8.4% receiving placebo, a 26% relative risk reduction; median treatment duration was 14.2 months.
Major bleeding rates were similar overall: 1.6 versus 1.5 events per 100 person-years.
Major bleeding rates were higher with asundexian among patients older than 75 years and during the first 90 days of treatment. Gastrointestinal bleeding, diarrhea, and hepatic enzyme elevations were also reported more frequently with asundexian.
Interpretation:
Asundexian inhibits activated factor XI and is approved as an addition to antiplatelet therapy for the specified post-stroke or high-risk TIA population.
Limitations:
The approval indication does not cover stroke prevention in patients with atrial fibrillation.
The supplied context does not provide subgroup efficacy results or longer-term outcomes beyond the reported median treatment duration.
Conclusion:
The prescribing information advises withholding asundexian for at least 24 hours before elective procedures and for at least 24 hours after thrombolysis for acute ischemic stroke. It may be resumed after procedures once adequate hemostasis is established. Routine coagulation monitoring is not recommended.
Baptist Health Brain & Spine Care Stroke Programs at nine Baptist Health hospitals have earned recognition from the American Heart Association and American Stroke Association.
