“Stroke is a leading cause of disability and death in the United States, and survivors are at risk of having another stroke,” said Hylton V. Joffe, MD, director of the Office of Cardiology, Hematology, Endocrinology, and Nephrology in the FDA’s Center for Drug Evaluation and Research. “Today’s approval represents a meaningful advance for patients and healthcare providers seeking a new option for secondary stroke prevention.”
“This could provide another important treatment option for patients who remain at high risk despite standard therapy,” says Christopher Yi, MD, a vascular surgeon at MemorialCare Orange Coast Medical Center in Fountain Valley, California.
Adults Who Took Asundexian Were 26 Percent Less Likely to Have Another Stroke
After a Stroke, Adults Are Often Closely Monitored and Treated to Prevent Recurrence
Doctors will often continue to treat and monitor patients after an initial stroke to try to prevent another stroke. “If they get another stroke, their chance of being disabled is quite high,” says Mukul Sharma, MD, lead study author in the phase 3 clinical trial and a professor of medicine at McMaster University in Hamilton, Ontario. “The goal is to get the risk [of recurrent stroke] as close to zero as we can.”
“Whatever caused your stroke in the first place is most likely still there,” says Lily Johnston, MD, a vascular surgeon at Scripps Clinic in La Jolla, California, and an ambassador for the Society for Vascular Surgery.
She cites high blood pressure, plaque in the arteries, atrial fibrillation (a type of irregular heartbeat), and diabetes as a few potential risk factors. “It’s crucially important that we try to double down on [lowering] those risk factors,” Dr. Johnston says. Dr. Yi agrees. “This is why patients who have experienced one stroke are at a significantly higher risk of having another, particularly during the first few months,” he says.
Doctors will typically try to determine what caused the stroke and refer patients to a specialist from there, Johnston says.
They will often recommend that patients focus on lifestyle changes as well, including optimal nutrition, managing insulin levels, moving regularly, and getting good sleep, according to Johnston.
“New medications like asundexian may offer additional protection, but they do not replace these proven preventive measures,” Yi says. “With appropriate treatment and risk factor management, many recurrent strokes can be prevented.”
Sunharbo Works Differently From Existing Stroke-Prevention Medications
Asundexian is a factor 11a inhibitor, meaning it targets a protein involved in harmful clot formation called factor 11a. This is different from traditional blood thinners like aspirin or prescription medications that are often used for stroke prevention. While those blood thinners can lower the risk of stroke, they also come with an increased risk of serious bleeding.
“The exciting thing about asundexian is that we may have a medication that provides additional protection against recurrent strokes without substantially increasing the risk of serious bleeding,” Yi says. “That has been one of the biggest challenges in stroke prevention.”
