FDA Approves First Factor Xla Inhibitor to Help Prevent Stroke in Certain Adults at High Risk

The U.S. Food and Drug Administration has approved Sunharbo (asundexian) 50 mg tablets, the first factor XIa (FXIa) 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 (a stroke caused by a clot that did not originate in the heart) or a high-risk transient ischemic attack (TIA), often called a “mini-stroke.”

“Stroke is a leading cause of disability and death in the United States, and survivors are at risk of having another stroke,” said Hylton V. Joffe, M.D., MMSc, Director of the Office of Cardiology, Hematology, Endocrinology, and Nephrology in the FDA’s Center for Drug Evaluation and Research. “Today’s approval represents a meaningful advance for patients and health care providers seeking a new option for secondary stroke prevention.”

The effectiveness of Sunharbo was demonstrated in the OCEANIC-STROKE study, a multicenter, randomized, double-blind, placebo-controlled phase 3 study that enrolled 12,327 adults. Participants had a recent non-cardioembolic ischemic stroke (NIH Stroke Scale ≤15) or high-risk TIA and were randomly assigned to Sunharbo or placebo within 72 hours of symptom onset. Both groups also received antiplatelet therapy. Sunharbo 50 mg once daily significantly reduced the risk of ischemic stroke by 26% compared to 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 compared to placebo. The most frequently reported adverse reaction (occurring in 3% or greater of Sunharbo-treated patients) was diarrhea.

Concomitant use with medicines that are 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. Sunharbo 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. Sunharbo is not approved for stroke prevention in patients with atrial fibrillation.

The FDA granted Sunharbo Fast Track and Priority Review designations. The approval was granted to Bayer HealthCare Pharmaceuticals Inc., Whippany, N.J.