The FDA has approved Sunharbo, also known as asundexian, to reduce the risk of recurring strokes in certain adults. The medication is intended for adults who recently experienced a stroke caused by a blood clot that did not originate in the heart or a transient ischemic attack, also called a TIA.

Sunharbo is taken as one 50 mg pill each day alongside standard medicine that helps prevent blood clots, such as aspirin. It is the first medication of its kind to block factor XIa, a specific blood protein involved in clot formation.

Dr. Richard Kovacs, a cardiologist at Indiana University School of Medicine and chief medical officer of the American College of Cardiology, discussed the newly approved medication with Fox News Digital. He explained that the drug blocks a specific protein within the blood clotting cascade.

The approval followed a phase 3 randomized trial involving 12,327 patients in 37 countries. Every participant had recently experienced either a noncardioembolic ischemic stroke or a high risk TIA.

Participants received 50 mg of asundexian orally once each day in addition to antiplatelet therapy. After a treatment period of 14.2 months, the group taking asundexian had a 26% relative reduction in ischemic stroke compared with those taking a placebo and antiplatelet therapy.

About 6.6% of patients taking asundexian experienced a stroke, compared with 8.8% of patients receiving a placebo. Kovacs cautioned, “So it doesn’t completely eliminate the risk of a second stroke.”

The risk of death from heart related causes, heart attack or stroke was also lower among those taking asundexian. Those outcomes occurred in 9.2% of patients receiving the medication and 11.1% of those receiving a placebo.

Death from any cause occurred among 10.5% of patients taking asundexian, compared with 12.3% of patients in the placebo group. Although the results favored the medication across these measures, the trial also identified important concerns involving bleeding.

Researchers did not find a significant overall increase in major bleeding, but the risk was higher within certain patient subgroups. Gastrointestinal bleeding was more common among people taking asundexian, while major bleeding increased among patients older than 75 during the first 90 days.

The findings were published in The New England Journal of Medicine on Nov. 9. Bayer, the manufacturer of asundexian, funded the trial, which included several limitations noted in the source.

Patients received treatment for an average of approximately 14 months, leaving the medication’s longer term safety and effectiveness unclear. The study also excluded patients with certain heart conditions and those who had experienced more severe strokes.

The medication is not intended for every patient who has suffered a stroke. “Importantly, this drug is not for patients who have had strokes due to atrial fibrillation or due to a valve problem in their heart,” Kovacs said.

Researchers noted that longer studies are needed to determine safety and effectiveness among older patients, underrepresented populations and patients with greater stroke severity. The findings therefore apply to the patient population included in the trial rather than every person facing a risk of another stroke.

Kovacs emphasized that patients should speak with their care team shortly after a stroke. “In the clinical trial that approved this drug, this drug was given very soon after the stroke – within 72 hours,” he said.

“So it’s important to have that conversation about whether this is a drug for the patient early on, often in the hospital.” His comments highlighted the limited window in which participants began receiving the medication during the trial.

Medication remains only one component of preventing another stroke, according to Kovacs. He said atherosclerosis, described as plaque buildup that can impair circulation and reduce blood flow to the brain, caused strokes in many of the patients.

Kovacs also urged stroke patients to stop smoking, keep cholesterol low, eat healthy foods and exercise. These measures should accompany medication when patients and their care teams determine that Sunharbo is appropriate.

More than 795,000 people in the United States experience a stroke each year, according to the CDC. That total includes approximately 185,000 people who have previously had a stroke, while about one in four stroke survivors experiences another within five years.