Asundexian, which will be sold under the brand name Sunharbo, is a daily pill that is the first to target a specific factor in the blood-clotting process that can contribute to stroke. In a study submitted to the FDA by Bayer, researchers found that the drug, when combined with an antiplatelet therapy such as aspirin, reduced the risk of an additional stroke by 26% in just over a year compared to people who received placebo and the antiplatelet therapy. The drug is approved for people who have recently had an ischemic stroke, which occur when clots block blood flow to the brain, or a transient ischemic attack caused by a temporary blockage of blood flow to the brain that doesn’t cause permanent damage.
There are two types of strokes: ischemic strokes, caused by blockages in the blood vessels, can impede blood flow to critical organs including the brain, and hemorrhagic strokes, caused by weakened blood vessels that burst in the brain and cause excessive bleeding. About 87% of strokes in the U.S. are ischemic.
Researchers have known for years that some people born with a genetically driven lower risk of stroke have lower levels of a compound involved in blood clotting, called Factor XIa, in their blood. It's a minor contributor to forming clots when the body experiences a major bleeding trauma like an injury, but it plays a bigger role in smaller vessel ruptures, some of which can contribute to stroke, says Shoamanesh.
Given the encouraging results in reducing the risk of recurrent strokes, Koenen says Bayer is exploring "if there are other benefits of asundexian we can bring to different patient populations.”
Asundexian will be available starting in November. Shoamanesh expects that in order to truly benefit from the drug, patients will have to take the daily pills for the rest of their lives. Data that tracked some of the study participants for several more years showed that those on the drug continued to show lower risk of stroke compared to those taking placebo. “That means that the drug continued to provide an advantage even at later time points,” he says. “So we expect this to be a lifelong drug based on the data. And we expect this will be the new standard of care.”
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