The US Food and Drug Administration (FDA) has approved Sunharbo (asundexian), the first inhibitor of coagulation factor XIa (FXIa). The drug is used in combination with antiplatelet therapy in adult patients who have experienced a mild-to-moderate non-cardioembolic ischemic stroke (a stroke not caused by a blood clot originating in the heart) or a high-risk transient ischemic attack (TIA, also known as a “mini-stroke”).
The efficacy of the new drug was demonstrated in a large-scale, Phase III, placebo-controlled clinical trial (OCEANIC-STROKE), involving 12,327 patients. Participants received either the drug or a placebo within 72 hours of symptom onset (both groups also received antiplatelet medications). The results showed that daily administration of Sunharbo at a 50 mg dose reduced the risk of recurrent ischemic stroke by 26% compared with placebo over an average follow-up period of 14.2 months.
Regarding safety, the overall rate of major bleeding was nearly identical in both groups. However, the risk was slightly higher among Sunharbo-treated patients over the age of 75 and during the first 90 days of treatment. Gastrointestinal bleeding was also reported more frequently compared with placebo, while diarrhea was identified as the most common adverse effect.
According to the regulator, Sunharbo is not indicated for preventing strokes associated with atrial fibrillation and is not recommended for patients with moderate or severe hepatic impairment. In addition, treatment should be discontinued at least 24 hours before elective surgery.
“Stroke is one of the leading causes of death and disability in the United States, and survivors face a high risk of experiencing another stroke. Today’s decision provides a new and important option for secondary stroke prevention,” said Dr. Hilton Joffe, Director of the FDA Center.
The regulator approved the drug, manufactured by Bayer, through the Fast Track and Priority Review pathways.
