The U.S. Food and Drug Administration on Monday approved Sunharbo (asundexian) 50 mg tablets, the first factor XIa inhibitor approved to reduce the risk of stroke in certain adults. The drug is approved for use in combination with antiplatelet therapy.
The approval covers adults after a recent mild-to-moderate non-cardioembolic ischemic stroke or a high-risk transient ischemic attack (TIA). A non-cardioembolic stroke is one caused by a clot that did not start in the heart. A TIA is often called a “mini-stroke.”
Hylton V. Joffe, M.D., director of the Office of Cardiology, Hematology, Endocrinology, and Nephrology in the FDA’s Center for Drug Evaluation and Research, said stroke is a leading cause of disability and death in the United States. He said survivors are at risk of having another stroke. He called the approval “a meaningful advance” for patients and health care providers seeking a new option for secondary stroke prevention.
The FDA said the drug’s effectiveness was shown in a study called OCEANIC-STROKE. It was a randomized, double-blind, placebo-controlled phase 3 study that enrolled 12,327 adults at multiple sites. Participants had a recent non-cardioembolic ischemic stroke or a high-risk TIA. They were randomly assigned to Sunharbo or a placebo within 72 hours of symptom onset, and both groups also received antiplatelet therapy.
According to the FDA, Sunharbo at 50 mg once daily significantly reduced the risk of ischemic stroke by 26% compared with placebo. The median treatment time was 14.2 months.
The FDA also described safety findings. The overall rate of major bleeding was similar in the Sunharbo and placebo groups. Major bleeding was increased with Sunharbo in patients older than 75 and during the first 90 days of treatment, and gastrointestinal bleeding was more common with Sunharbo than with placebo.
The most frequently reported adverse reaction, occurring in 3% or more of Sunharbo-treated patients, was diarrhea.
The FDA said use with medicines that are combined P-gp and strong CYP3A4 inducers, such as carbamazepine, is not recommended because they may decrease the drug’s effectiveness. Sunharbo is also not recommended for patients with moderate or severe hepatic (liver) impairment. It should be withheld at least 24 hours before elective surgery or invasive procedures, and for at least 24 hours after thrombolysis for acute ischemic stroke.
According to the FDA, Sunharbo is not approved for stroke prevention in patients with atrial fibrillation.
The agency granted the drug Fast Track and Priority Review designations. The approval was granted to Bayer HealthCare Pharmaceuticals Inc. of Whippany, New Jersey. The announcement did not give a price or say when the drug will be available.