Neurology ·
FDA Approves Asundexian for Secondary Stroke Prevention After Non-Cardioembolic Events
The FDA approved asundexian (Sunharbo) with antiplatelet therapy for adults after a recent mild-to-moderate non-cardioembolic ischemic stroke or high-risk TIA. Approval was based on the randomized, placebo-controlled phase 3 OCEANIC-STROKE trial, which enrolled 12,327 adults and found a 26% relative reduction in ischemic stroke risk over a median 14.2 months.
- Phase 3 trial enrolled 12,327 adults after stroke or high-risk TIA.
- Ischemic stroke risk fell 26% versus placebo.
- Gastrointestinal bleeding was more common with asundexian.
- Not approved for stroke prevention in atrial fibrillation.
The FDA approved asundexian (Sunharbo) 50 mg once daily, in combination with antiplatelet therapy, to reduce stroke risk in adults following a recent mild-to-moderate non-cardioembolic ischemic stroke or high-risk transient ischemic attack. The approval was based on OCEANIC-STROKE, a multicenter, randomized, double-blind, placebo-controlled phase 3 trial. It enrolled 12,327 adults, who were assigned to asundexian or placebo within 72 hours of symptom onset; both groups received antiplatelet therapy.
Over a median treatment period of 14.2 months, asundexian reduced ischemic stroke risk by 26% compared with placebo. The overall rate of major bleeding was similar between groups, but bleeding was increased among patients older than 75 years and during the first 90 days of treatment. Gastrointestinal bleeding was more common with asundexian; diarrhea was the most frequently reported adverse reaction, occurring in at least 3% of treated patients.
The FDA advises against use with combined P-gp and strong CYP3A4 inducers and in moderate or severe hepatic impairment. The drug is not approved for stroke prevention in atrial fibrillation. It should be withheld around elective procedures and for at least 24 hours after thrombolysis. The FDA granted Fast Track and Priority Review; approval was issued to Bayer HealthCare Pharmaceuticals.
In practice
For adults with a recent mild-to-moderate non-cardioembolic ischemic stroke or high-risk TIA, the FDA has approved asundexian 50 mg once daily alongside antiplatelet therapy, based on a phase 3 trial showing a 26% relative reduction in ischemic stroke versus placebo. Overall major bleeding rates were similar, but gastrointestinal bleeding was more common, with increased bleeding noted in patients older than 75 years and during the first 90 days. It is not approved for atrial-fibrillation-related stroke prevention, and specified drug interactions and hepatic impairment limit use.
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