FDA Approves First Factor Xla Inhibitor to Help Prevent Stroke

The FDA approved Sunharbo (asundexian) 50 mg tablets as the first factor XIa inhibitor for preventing repeat stroke in certain high-risk adults. It is used alongside antiplatelet therapy after a recent mild-to-moderate ischemic stroke caused by a clot that did not originate in the heart, or after a high-risk transient ischemic attack. The approval is based on OCEANIC-STROKE, a randomized, placebo-controlled study of 12,327 adults who began treatment within 72 hours of symptoms. Over a median 14.2 months, once-daily Sunharbo reduced ischemic stroke risk by 26% compared with placebo.

Overall major bleeding rates were similar between the treatment groups, but major bleeding was more common among Sunharbo recipients older than 75 and during the first 90 days of treatment. Gastrointestinal bleeding also occurred more often with the drug; diarrhea was its most frequently reported adverse reaction, affecting at least 3% of treated patients. Sunharbo is not recommended with certain medicines, including strong CYP3A4 and P-gp inducers, or for people with moderate or severe liver impairment. It should be paused around elective surgery or invasive procedures and for at least 24 hours after thrombolysis for acute ischemic stroke. The drug is not approved to prevent stroke in people with atrial fibrillation.