The FDA has approved asundexian (Sunharbo, Bayer) 50 mg tablets, a first-in-class factor XIa inhibitor, for use with antiplatelet therapy to reduce the risk for stroke in adults following a recent mild-to-moderate noncardioembolic ischemic stroke or high-risk transient ischemic attack (TIA). 

As previously reported, the phase 3 OCEANIC-STROKE trial showed that adding asundexian to standard antiplatelet therapy reduced recurrent ischemic stroke by 26% compared with antiplatelet therapy alone, without a statistically significant increase in major bleeding. 

The multicenter, double-blind, randomized, placebo-controlled phase 3 study enrolled 12,327 patients within 72 hours of a noncardioembolic ischemic stroke (National Institutes of Health Stroke Scale ≤ 15) or high-risk TIA. 

Participants received asundexian 50 mg once daily or placebo, added to planned single or dual antiplatelet therapy. Eligibility required evidence of a nonlacunar infarct or atherosclerotic disease. Median follow-up was approximately 19 months.

Over a median treatment period of 14.2 months, recurrent ischemic stroke occurred in 6.2% of patients receiving asundexian vs 8.4% receiving placebo (hazard ratio, 0.74; P < .001).

The overall rate of major bleeding was similar between asundexian and placebo groups (1.9% and 1.7%, respectively) but was increased in patients older than 75 years and during the first 90 days of treatment, the FDA noted in a statement. Gastrointestinal bleeding was also more frequent with asundexian. 

The most commonly reported adverse reaction, occurring in at least 3% of treated patients, was diarrhea.

Concomitant use of asundexian with medicines that are combined P-glycoprotein and strong CYP3A4 inducers, such as carbamazepine, is not recommended because these medicines may decrease the effectiveness of asundexian, the FDA said. 

Asundexian is not approved for stroke prevention in patients with atrial fibrillation and is not recommended in patients with moderate or severe hepatic impairment. Treatment 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. Full prescribing information is available online.

The FDA granted asundexian fast track and priority review status. In October, China became the first country to approve the drug, making it the first factor XIa inhibitor to receive regulatory approval worldwide.