FDA approves Sunharbo, a new drug to prevent a second stroke

The U.S. Food and Drug Administration (FDA) on Monday approved Sunharbo (asundexian), a new drug to reduce the risk of another stroke in adults who already had a mild or moderate one, or a transient ischemic attack, known as a mini-stroke.

Sunharbo, from drugmaker Bayer, is the first factor XIa inhibitor approved in the United States. It is taken once a day, in 50-milligram tablets, alongside standard antiplatelet therapy. The approval was based on the OCEANIC-STROKE study of 12,327 adults, in which the drug reduced the risk of ischemic stroke by 26% compared with placebo, without a significant increase in major bleeding, according to the FDA.

The agency granted the drug Fast Track and Priority Review designations. Bayer expects Sunharbo to begin shipping in mid-to-late November and to soon be available for hospitals and pharmacies across the country.

The approval covers a specific group: it does not include stroke prevention in patients with atrial fibrillation, and the drug is not recommended for people with moderate or severe liver damage. Patients should ask their doctor whether the treatment is right for them.

Photo: AJMC

Source: FDA