FDA Approves Sunharbo, First Pill of Its Kind to Cut Repeat Stroke Risk

The FDA approved Sunharbo, known generically as asundexian, for adults who recently had an ischemic stroke caused by a clot that didn't start in the heart, or a transient ischemic attack — the fleeting blockage often called a mini-stroke. Patients take one 50-milligram pill a day on top of standard antiplatelet therapy like aspirin to help keep clots from forming. It's the first approved medication of its kind to inhibit factor XIa, a blood protein involved in clotting.

The green light rests on a phase 3 randomized trial of 12,327 patients in 37 countries, all of whom had recently suffered a non-cardioembolic ischemic stroke or a high-risk TIA. Over roughly 14.2 months, those on 50 milligrams of asundexian plus antiplatelet therapy saw a 26% lower relative risk of ischemic stroke than those given a placebo with antiplatelet therapy. Strokes hit 6.6% of the asundexian group versus 8.8% on placebo.

Bleeding didn't rise significantly overall, but researchers flagged trouble spots: gastrointestinal bleeding was more frequent on asundexian, and patients over 75 faced a higher risk of major bleeding in the first 90 days. "So it doesn't completely eliminate the risk of a second stroke," 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. "This blocks a very specific protein that's part of the cascade of blood clotting."

The combined rate of heart-related death, heart attack or stroke came in at 9.2% for asundexian patients against 11.1% for placebo, and deaths from any cause landed at 10.5% versus 12.3%. The findings ran in The New England Journal of Medicine on Nov. 9. Bayer, which makes asundexian, funded the trial.

Researchers listed limitations: a treatment period averaging about 14 months leaves long-term safety and effectiveness open, and people with certain heart conditions or more severe strokes were excluded. "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.

Kovacs said the conversation with a care team should happen fast — in the trial, the drug was given within 72 hours of a stroke, often while patients were still in the hospital. He tied most of these strokes to atherosclerosis, plaque buildup that chokes off blood flow to the brain, and said medication alone isn't enough: quitting smoking, keeping cholesterol low, eating healthy and exercise all matter. More than 795,000 Americans have a stroke each year, including about 185,000 who've had one before, per the CDC, and roughly one in four survivors has another within five years.