Factor XIa Inhibitor for Stroke Prevention: FDA Approves Sunharbo

The FDA has approved Sunharbo (asundexian) 50 mg tablets, the first factor XIa inhibitor for stroke prevention, for adults after a recent mild-to-moderate non-cardioembolic ischemic stroke or a high-risk transient ischemic attack (TIA). It is taken alongside antiplatelet therapy. The FDA granted Sunharbo Fast Track and Priority Review designations, and Bayer HealthCare Pharmaceuticals Inc. holds the approval.

Trial results and bleeding

The OCEANIC-STROKE trial enrolled 12,327 adults and randomly assigned them to Sunharbo or placebo, with antiplatelet therapy in both groups. Sunharbo 50 mg once daily significantly reduced the risk of ischemic stroke by 26% compared with placebo over a median treatment of 14.2 months. Hylton V. Joffe, M.D., MMSc, of the FDA’s Center for Drug Evaluation and Research, called it “a meaningful advance for patients and health care providers seeking a new option for secondary stroke prevention.”

Overall major bleeding was similar between groups, but it rose with Sunharbo in patients older than 75 and during the first 90 days of treatment. Diarrhea was the most frequently reported adverse reaction, in 3% or greater of treated patients. Sunharbo should be withheld at least 24 hours before elective surgery or invasive procedures, and it is not recommended with P-gp and strong CYP3A4 inducers such as carbamazepine or in moderate or severe hepatic impairment.

Why this factor XIa inhibitor for stroke prevention matters

The release gives only the relative reduction, with no absolute event rates or bleeding counts, so the size of the trade-off cannot be read from it. Syenza News previously reported on Bayer’s marketing authorization application for asundexian at the EMA. The FDA did not approve it for atrial fibrillation, where direct oral anticoagulants are typically used.

Source: FDA News Release, FDA Approves First Factor XIa Inhibitor to Help Prevent Stroke in Certain Adults at High Risk