The FDA has approved Sunharbo (asundexian) 50 mg tablets, the first factor XIa inhibitor, for use in combination with antiplatelet therapy to reduce the risk of stroke in adults following a recent mild-to-moderate non-cardioembolic ischemic stroke or a high-risk transient ischemic attack, often called a "mini-stroke." The approval was granted to Bayer HealthCare Pharmaceuticals.
Effectiveness was demonstrated in the OCEANIC-STROKE study, a Phase 3, randomized, double-blind, placebo-controlled trial of 12,327 adults. Participants had a recent non-cardioembolic ischemic stroke (NIH Stroke Scale ≤15) or high-risk TIA and were randomized to Sunharbo or placebo within 72 hours of symptom onset; both groups also received antiplatelet therapy. Sunharbo 50 mg once daily reduced the risk of ischemic stroke by 26% compared with placebo over a median treatment of 14.2 months.
The overall rate of major bleeding was similar between the Sunharbo and placebo groups but was increased with Sunharbo in patients older than 75 years and during the first 90 days of treatment. Gastrointestinal bleeding occurred more commonly with Sunharbo, and the most frequently reported adverse reaction, occurring in 3% or more of treated patients, was diarrhea.
Concomitant use with combined P-gp and strong CYP3A4 inducers such as carbamazepine is not recommended because these medicines may decrease Sunharbo's effectiveness. Sunharbo is not recommended in patients with moderate or severe hepatic impairment, should be withheld at least 24 hours before elective surgery or invasive procedures and for at least 24 hours after thrombolysis for acute ischemic stroke, and is not approved for stroke prevention in patients with atrial fibrillation.
The FDA granted Sunharbo Fast Track and Priority Review designations.
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