FDA approves Sunharbo for stroke prevention in certain adults

The Food and Drug Administration approved Sunharbo (asundexian) on November 9 to reduce stroke risk in a defined group of adults, when used with antiplatelet therapy.

The FDA said the approval applies after a recent mild-to-moderate non-cardioembolic ischemic stroke or a high-risk transient ischemic attack. It does not approve the drug for stroke prevention in patients with atrial fibrillation.

In a randomized, double-blind trial of 12,327 adults, the agency reported a 26% relative reduction in ischemic stroke risk with Sunharbo compared with placebo over a median 14.2 months of treatment. Both groups received antiplatelet therapy.

Overall major bleeding rates were similar between groups, the FDA said. Major bleeding was higher with Sunharbo among patients older than 75; it was also higher during the first 90 days of treatment. Gastrointestinal bleeding was more common with Sunharbo than placebo.

Cardiologist Richard Kovacs told Fox News that the medicine does not eliminate the risk of another stroke. He also distinguished patients whose strokes stem from atrial fibrillation or heart-valve problems from those for whom the treatment is intended.