The FDA has approved a first-of-its-kind blood drug designed to reduce repeat stroke risk.
Asundexian, sold under the brand name Sunharbo, is a daily pill that targets a specific factor in the blood-clotting process. A study found the drug combined with an antiplatelet therapy such as aspirin reduced the risk of an additional stroke by 26 percent in just over a year compared with placebo and therapy. The FDA approved it for people who recently had an ischemic stroke or a transient ischemic attack caused by a temporary blockage of blood flow to the brain. Recurrent strokes are an unmet treatment challenge, and treating ischemic strokes requires using just enough clot-breaking medication to dissolve a blockage without causing excessive bleeding. Asundexian appeared to do that, with the 26 percent reduction occurring without a significant increase in bleeding events. Researchers said it took more than a decade to turn a genetic observation into a viable medication, and Bayer is exploring other uses. Asundexian will be available starting in November, and one researcher expects patients will need to take the daily pill for life.