FDA Approves New Class of Pill to Help Prevent Repeat Strokes

The FDA has approved Sunharbo, a new type of medicine to help prevent another stroke in certain adults who recently had a clot-related stroke or a high-risk transient ischemic attack, often called a mini-stroke.

The once-daily 50-milligram tablet, also known as asundexian, is the first approved factor XIa inhibitor. It is used alongside antiplatelet therapy. The approval covers recent mild-to-moderate ischemic strokes caused by clots that did not originate in the heart, and certain high-risk TIAs. It is not approved for stroke prevention in people with atrial fibrillation.

In a trial involving 12,327 adults, Sunharbo reduced the risk of ischemic stroke by 26% compared with placebo over a median treatment period of 14.2 months. Both groups also received antiplatelet therapy. That figure is a relative reduction, not a 26-percentage-point drop in risk.

The FDA said overall major bleeding rates were similar between the groups, but major bleeding increased with Sunharbo among patients older than 75 and during the first 90 days of treatment. Gastrointestinal bleeding was also more common. Diarrhea was the most frequently reported side effect.

The medicine has additional precautions involving drug interactions, liver disease and procedures. Patients should discuss whether it is appropriate with their health care provider. The approval was granted to Bayer HealthCare Pharmaceuticals in Whippany, New Jersey.