FDA approves Sunharbo to lower the risk of another stroke after a mild-to-moderate stroke or mini-stroke
With antiplatelet drugs, Sunharbo cut ischemic stroke risk 26% relative to placebo in a 12,327-person trial, FDA says. Major bleeding rose in people over 75.
What it means for you
- The FDA approved Bayer's Sunharbo (asundexian) on November 9 for adults who recently had a mild-to-moderate stroke caused by a clot not from the heart, or a high-risk mini-stroke.
- It is taken with antiplatelet therapy, and the FDA calls it the first factor XIa inhibitor.
- Major bleeding was similar to placebo overall but higher in patients over 75 and in the first 90 days, the FDA says. It is not approved for people with atrial fibrillation.
- About 185,000 U.S. strokes a year, nearly 1 in 4, happen in people who have had a stroke before, according to the CDC.