FDA approves Bayer's Sunharbo, first factor XIa inhibitor, for secondary stroke prevention
Asundexian 50 mg tablets, taken with antiplatelet therapy, reduced ischemic stroke risk by 26% versus placebo in a phase 3 trial of 12,327 adults.
The U.S. Food and Drug Administration has approved Sunharbo (asundexian) 50 mg tablets, according to fda.gov. It is the first factor XIa (FXIa) inhibitor approved for use together with antiplatelet therapy to reduce stroke risk in adults after a recent mild-to-moderate non-cardioembolic ischemic stroke or a high-risk transient ischemic attack (TIA). Non-cardioembolic means the clot did not originate in the heart. The approval was granted to Bayer HealthCare Pharmaceuticals Inc., Whippany, N.J. fda.gov
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The agency gave the drug Fast Track and Priority Review designations. Factor XIa is a blood-clotting protein that amplifies the coagulation cascade, according to biopharmadive.com.
Phase 3 results
Effectiveness was shown in OCEANIC-STROKE, a multicenter, randomized, double-blind, placebo-controlled phase 3 study of 12,327 adults. Participants had a recent non-cardioembolic ischemic stroke (NIH Stroke Scale ≤15) or a high-risk TIA. They were randomly assigned to Sunharbo or placebo within 72 hours of symptom onset, and 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. fda.gov
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The overall rate of major bleeding was similar in the two groups. It was higher with Sunharbo in patients older than 75 years and during the first 90 days of treatment. Gastrointestinal bleeding was more common with Sunharbo than with placebo. The most frequent adverse reaction, in 3% or more of treated patients, was diarrhea.
Restrictions and use
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.
Sunharbo should be withheld for at least 24 hours before elective surgery or invasive procedures, and for at least 24 hours after thrombolysis for acute ischemic stroke. It is not approved for stroke prevention in patients with atrial fibrillation. fda.gov
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A Bayer spokesperson told biopharmadive.com that a 30-day supply will have a list price of $748.50.
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