The US Food and Drug Administration (FDA) has approved Sunharbo (asundexian) 50 mg tablets, the first factor XIa (FXIa) inhibitor indicated for use in combination with antiplatelet therapy to reduce the risk of stroke in adults following a recent mild-to-moderate non-cardioembolic ischaemic stroke or a high-risk transient ischaemic attack (TIA), commonly known as a mini-stroke.
The FDA granted marketing approval to Bayer HealthCare Pharmaceuticals, based in Whippany, New Jersey. Sunharbo had previously received Fast Track and Priority Review designations from the agency.
The approval is based on findings from the OCEANIC-STROKE study, a multicentre, randomised, double-blind, placebo-controlled Phase III clinical trial involving 12,327 adults.
Participants who had experienced a recent non-cardioembolic ischaemic stroke or a high-risk TIA were randomly assigned to receive either Sunharbo or placebo within 72 hours of symptom onset. Both groups also received antiplatelet therapy.
Sunharbo 50 mg, administered once daily, reduced the risk of ischaemic stroke by 26% compared with placebo over a median treatment period of 14.2 months.
The overall rate of major bleeding was similar between the two groups. However, an increased risk of major bleeding was observed among patients older than 75 years and during the first 90 days of treatment.
Gastrointestinal bleeding was also more common in patients receiving Sunharbo. Diarrhoea was the most frequently reported adverse reaction, occurring in at least 3% of Sunharbo-treated patients.
Commenting on the approval, Hylton V Joffe, Director of the Office of Cardiology, Haematology, Endocrinology, and Nephrology at the FDA’s Center for Drug Evaluation and Research, said the approval represents a meaningful advance for patients and healthcare providers seeking new options for secondary stroke prevention.
The FDA has advised against the concomitant use of Sunharbo with medicines that are both P-glycoprotein (P-gp) and strong CYP3A4 inducers, such as carbamazepine, as they may reduce the drug’s effectiveness.
The medicine is also not recommended for patients with moderate or severe hepatic impairment.
Further, the agency said Sunharbo should be withheld for at least 24 hours before elective surgery or invasive procedures and for at least 24 hours after thrombolysis for acute ischaemic stroke. It is not approved for stroke prevention in patients with atrial fibrillation.
