The FDA has approved Bayer’s Sunharbo (asundexian), the first factor XIa inhibitor, after a phase 3 trial found the drug reduced the risk of ischemic stroke by 26% compared with placebo over a median treatment period of 14.2 months.
The approval rests on OCEANIC-STROKE, a phase 3, placebo-controlled trial of 12,327 adults with a recent non-cardioembolic ischemic stroke or high-risk TIA who were randomized within 72 hours of symptom onset. All participants also received antiplatelet therapy. Sunharbo is approved for use with antiplatelet therapy to reduce the risk of another stroke in adults after a recent mild-to-moderate non-cardioembolic ischemic stroke or a high-risk transient ischemic attack, the agency announced Nov. 9.
The overall rate of major bleeding was similar between Sunharbo and placebo, but it was higher with Sunharbo in patients older than 75 and during the first 90 days of treatment. Gastrointestinal bleeding also occurred more often with Sunharbo. The most common adverse reaction was diarrhea, occurring in 3% or more of treated patients.
The FDA said combined P-gp and strong CYP3A4 inducers, such as carbamazepine, are not recommended with Sunharbo because they may reduce its effectiveness. The drug 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.
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