FDA Approves Sunharbo (asundexian) as First FXIa Inhibitor for Secondary Stroke Prevention

The U.S. Food and Drug Administration (FDA) has approved Sunharbo (asundexian) 50 mg tablets, marking the first approval of a factor XIa (FXIa) inhibitor. The agency approved the drug for use in combination with antiplatelet therapy to reduce the risk of stroke in adults following a recent mild-to-moderate non-cardioembolic ischemic stroke or a high-risk transient ischemic attack (TIA).

According to the FDA, the approval was granted to Bayer HealthCare Pharmaceuticals Inc. of Whippany, N.J. The effectiveness of the drug was established through the OCEANIC-STROKE study, a multicenter, randomized, double-blind, placebo-controlled phase 3 trial. The study enrolled 12,327 adults who had experienced a non-cardioembolic ischemic stroke or a high-risk TIA.

Participants were randomly assigned to receive Sunharbo or placebo within 72 hours of symptom onset, with both groups continuing antiplatelet therapy. The data showed that Sunharbo 50 mg once daily significantly reduced the risk of ischemic stroke by 26% compared to placebo over a median treatment duration of 14.2 months.

The FDA noted that the overall rate of major bleeding was similar between the Sunharbo and placebo groups. However, bleeding was increased with Sunharbo in patients older than 75 years and during the first 90 days of treatment. Gastrointestinal bleeding occurred more commonly with Sunharbo compared to placebo. The most frequently reported adverse reaction in Sunharbo-treated patients was diarrhea.

The FDA granted Sunharbo Fast Track and Priority Review designations. The agency has outlined specific warnings regarding the drug's use, including that it is not recommended for patients with moderate or severe hepatic impairment. Additionally, concomitant use with medicines that are combined P-gp and strong CYP3A4 inducers, such as carbamazepine, is not recommended as it may decrease Sunharbo's effectiveness. 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 ischemic stroke. The drug is not approved for stroke prevention in patients with atrial fibrillation.