The FDA has cleared Sunharbo (asundexian) 50 mg pills, marking the initial factor XIa (FXIa) inhibitor. This treatment aims to lower stroke danger for adults who experienced a mild-to-moderate non-cardioembolic ischemic stroke or a high-risk transient ischemic attack (TIA).
“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 drug’s effectiveness was demonstrated in the OCEANIC-STROKE study, a phase 3 trial involving 12,327 adults. Participants received either Sunharbo or a placebo within 72 hours of their stroke symptoms, in addition to antiplatelet therapy. Over a median treatment period of 14.2 months, Sunharbo reduced the risk of ischemic stroke by 26% compared to the placebo.
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While the overall rate of major bleeding was similar between the two groups, Sunharbo was linked to increased bleeding in patients over 75 and during the first 90 days of treatment. Gastrointestinal bleeding was also more frequent with Sunharbo. The most common side effect was diarrhea, occurring in 3% or more of patients.
The FDA advises against using Sunharbo with medications like carbamazepine that can reduce its effectiveness. It is also not recommended for patients with moderate or severe hepatic impairment. The drug should be discontinued at least 24 hours before surgery or invasive procedures and after thrombolysis for acute ischemic stroke. Sunharbo is not approved for stroke prevention in patients with atrial fibrillation.