The U.S. Food and Drug Administration (FDA) has approved a new medication, asundexian, to reduce the risk of recurrent strokes in certain adults. Marketed under the brand name Sunharbo, the daily pill is the first to target a specific element in the blood-clotting process that contributes to stroke.
In a study submitted to the FDA, researchers found that asundexian, when used with an antiplatelet therapy like aspirin, decreased the risk of a subsequent stroke by 26% over approximately one year compared to a placebo with antiplatelet therapy. The drug is indicated for individuals who have recently experienced an ischemic stroke, which occurs when blood clots obstruct blood flow to the brain, or a transient ischemic attack (TIA), a temporary blockage causing no permanent damage.
Ischemic strokes account for about 87% of strokes in the U.S. Each year, approximately 795,000 people in the United States have a stroke, and nearly a quarter of these occur in individuals who have previously had one. Recurrent strokes present a significant treatment challenge, requiring a careful balance to thin the blood sufficiently to dissolve blockages without inducing excessive bleeding.
Asundexian targets Factor XIa, a compound involved in blood clotting. While a minor contributor to clot formation during major trauma, it plays a more significant role in smaller vessel ruptures that can lead to stroke. Developing asundexian took over a decade, according to Bayer officials. The drug functions by preventing small clots in blood vessels from enlarging and blocking blood flow.
Bayer reported that the 26% reduction in stroke risk was achieved without a significant increase in bleeding events. Researchers noted that the drug's benefits appeared consistent across various patient demographics, including age, geographic origin, medical history, and stroke type. Bayer is exploring potential benefits of asundexian for other patient populations.
Asundexian is expected to be available in November. Based on data tracking participants for several years, showing continued lower stroke risk compared to placebo, researchers anticipate that patients will need to take the daily medication long-term, potentially for life, and suggest it may become the new standard of care for this patient group.