FDA Approves Sunharbo, the First Factor XIa Inhibitor to Help Prevent Repeat Strokes

The Food and Drug Administration has approved Sunharbo, a once-daily pill that gives doctors a new way to lower the risk of a second stroke in certain adults. The agency announced the approval on Monday, November 9.

Sunharbo, known by its generic name asundexian, is the first drug in a class called factor XIa inhibitors to win FDA approval. It is taken in combination with antiplatelet therapy by adults who recently had a mild-to-moderate non-cardioembolic ischemic stroke, a stroke caused by a clot that did not start in the heart, or a high-risk transient ischemic attack, often called a mini-stroke.

“Stroke is a leading cause of disability and death in the United States, and survivors are at risk of having another stroke,” said Dr. Hylton V. Joffe, director of the FDA office that oversees heart and blood drugs. “Today’s approval represents a meaningful advance for patients and health care providers seeking a new option for secondary stroke prevention.”

What the trial showed

The approval rests on the OCEANIC-STROKE study, a phase 3 trial that enrolled 12,327 adults at 702 centers in 37 countries. Patients were assigned at random to Sunharbo or a placebo within 72 hours of their stroke or mini-stroke, and both groups also received antiplatelet therapy. Over a median treatment period of 14.2 months, Sunharbo 50 mg once daily cut the risk of ischemic stroke by 26 percent compared with placebo. In the trial, 6.2 percent of patients who took asundexian had an ischemic stroke, compared with 8.4 percent who took a placebo, according to NeurologyLive.

The need for better prevention is clear. About one in 10 stroke survivors has another stroke within a year, and about one in five has another within five years, according to Bayer, the company that makes the drug.

Limits and side effects

The overall rate of major bleeding was similar in the Sunharbo and placebo groups, the FDA said, but bleeding was more common with Sunharbo in patients older than 75 and during the first 90 days of treatment. Bleeding in the stomach and intestines also occurred more often with Sunharbo. The most frequently reported side effect was diarrhea, which affected at least 3 percent of patients who took the drug.

Sunharbo is not approved to prevent stroke in patients with atrial fibrillation, and it is not recommended for patients with moderate or severe liver impairment. The FDA said patients should stop taking it at least 24 hours before elective surgery or invasive procedures, and for at least 24 hours after clot-busting treatment for an acute ischemic stroke. It should not be taken with medicines that combine a P-gp inducer and a strong CYP3A4 inducer, such as carbamazepine, because those drugs can reduce its effect.

The FDA gave Sunharbo fast track and priority review status. The approval was granted to Bayer HealthCare Pharmaceuticals Inc. of Whippany, New Jersey. Bayer said it expects the drug to begin shipping in mid-to-late November. China’s drug regulator approved the medicine on October 26, and it is under review by the European Medicines Agency and Japan’s Ministry of Health, Labour and Welfare.

Reporting based on coverage by the U.S. Food and Drug Administration, Healio and NeurologyLive.