FDA approves daily pill shown to cut repeat stroke risk by 26%

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The Details

The FDA approved Sunharbo, a daily pill that helps prevent repeat strokes in certain adults.

The drug reduced the relative risk of ischemic stroke by 26% when combined with standard antiplatelet treatment.

Major bleeding did not increase significantly overall, but some patient groups faced higher risks.

The Food and Drug Administration has approved Sunharbo (asundexian) to help prevent another stroke in certain adults.

Patients take one 50-milligram pill daily alongside standard antiplatelet treatment, such as aspirin, to help prevent blood clots.

According to the FDA release, the medication is intended for adults who recently experienced an ischemic stroke caused by a clot that did not originate in the heart, or a transient ischemic attack. Often called a mini-stroke, a TIA occurs when blood flow to the brain is temporarily interrupted.

Sunharbo is the first approved medication of its kind to inhibit factor XIa, a blood protein involved in clot formation.

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"This blocks a very specific protein that’s part of the cascade of blood clotting," Dr. Richard Kovacs, a cardiologist at Indiana University School of Medicine and chief medical officer of the American College of Cardiology, told Fox News Digital.

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The backstory

The approval was based on a phase 3 randomized trial of 12,327 patients in 37 countries. All participants had recently experienced a non-cardioembolic ischemic stroke or a high-risk TIA.

Over approximately 14.2 months, patients who received 50 milligrams of asundexian daily alongside antiplatelet therapy had a 26% lower relative risk of ischemic stroke than those given a placebo with antiplatelet therapy.

Major bleeding did not increase significantly overall, though researchers identified higher risks in some groups. Gastrointestinal bleeding occurred more frequently among patients taking asundexian, and patients older than 75 had an increased risk of major bleeding during the first 90 days.

About 6.6% of patients receiving asundexian had a stroke, compared with 8.8% of those receiving a placebo.

"So it doesn’t completely eliminate the risk of a second stroke," Kovacs said.

The combined rate of death from heart-related causes, heart attack or stroke was also lower in the asundexian group, at 9.2%, compared with 11.1% in the placebo group.

Deaths from any cause occurred in 10.5% of patients taking the medication and 12.3% of those taking a placebo.

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Bayer, which manufactures asundexian, funded the trial. Researchers acknowledged several limitations, including a treatment period averaging about 14 months that leaves questions about the drug’s long-term safety and effectiveness.

Patients with certain heart conditions or more severe strokes were excluded from the study.

"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.

What's next

Researchers said longer studies are needed to evaluate the medication in older adults, underrepresented populations and people who have experienced more severe strokes.

Kovacs said patients should speak with their care team about the medication 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."

He also stressed that preventing another stroke requires more than medication.

"The cause of the stroke in many of these patients was atherosclerosis," he said, describing the condition as "plaque buildup that can cause circulation problems and the lack of blood flow to the brain."

"So it’s important for any stroke patient to do all the other things that you can do in addition to this medicine to prevent a second stroke – like stopping smoking, keeping your cholesterol low, eating healthy, and most importantly, getting exercise."

By the numbers

More than 795,000 people experience a stroke in the United States annually, including approximately 185,000 who have had a previous stroke, according to the Centers for Disease Control and Prevention.

About one in four stroke survivors has another stroke within five years.

The Source

FOX News contributed to this report. Information in this story came from an FDA announcement, findings from a Bayer-funded clinical trial published in The New England Journal of Medicine, and Fox News Digital’s interview with Dr. Richard Kovacs, chief medical officer of the American College of Cardiology. Stroke statistics came from the Centers for Disease Control and Prevention. This story was reported from Los Angeles.