The U.S. Food and Drug Administration has approved Sunharbo (asundexian) 50 mg tablets, establishing the first factor XIa (FXIa) inhibitor for use in combination with antiplatelet therapy. The drug is indicated to reduce the risk of stroke in adults who have recently experienced a mild-to-moderate non-cardioembolic ischemic stroke or a high-risk transient ischemic attack (TIA).
Non-cardioembolic ischemic strokes are caused by clots that do not originate in the heart. TIAs, often referred to as mini-strokes, are temporary periods of neurological dysfunction caused by lack of blood flow to the brain. This approval provides a new mechanism for secondary stroke prevention in a patient population that remains at significant risk for recurrence.
Clinical Trial Results and Efficacy
The approval is based on data from the OCEANIC-STROKE study, a multicenter, randomized, double-blind, placebo-controlled phase 3 trial. The study enrolled 12,327 adults who had a recent non-cardioembolic ischemic stroke or high-risk TIA. Participants were randomly assigned to receive either Sunharbo or a placebo within 72 hours of symptom onset. All participants continued to receive standard antiplatelet therapy.
Over a median treatment period of 14.2 months, patients taking Sunharbo 50 mg once daily experienced a 26% reduction in the risk of ischemic stroke compared to those taking the placebo. The study demonstrated that the addition of this FXIa inhibitor to existing antiplatelet regimens provided a statistically significant benefit in preventing recurrent events.
Safety Profile and Usage Restrictions
While the overall rate of major bleeding was similar between the Sunharbo and placebo groups, the FDA noted specific safety concerns. Bleeding risks were increased in patients older than 75 years and during the first 90 days of treatment. Gastrointestinal bleeding occurred more frequently in the Sunharbo group than in the placebo group. The most common adverse reaction, reported in 3% or more of patients, was diarrhea.
The prescribing information includes several restrictions. Concomitant use with medicines that are combined P-gp and strong CYP3A4 inducers, such as carbamazepine, is not recommended because these drugs may decrease the effectiveness of Sunharbo. The medication is also not recommended for patients with moderate or severe hepatic impairment.
Physicians are advised to withhold Sunharbo at least 24 hours before elective surgery or invasive procedures. It should also be withheld for at least 24 hours after thrombolysis for acute ischemic stroke. The drug is not approved for stroke prevention in patients with atrial fibrillation, as its efficacy in that population was not established in the clinical trials.
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, stated that stroke is a leading cause of disability and death in the United States. He noted that survivors are at continued risk of having another stroke, and today’s approval represents a meaningful advance for patients and health care providers seeking a new option for secondary stroke prevention.
Bayer HealthCare Pharmaceuticals Inc. of Whippany, New Jersey, received the approval. The FDA granted Sunharbo Fast Track and Priority Review designations during the development process. The drug is now available for prescription by healthcare professionals for eligible patients.
Source: U.S. FDA
