Abstract:
On November 9, the U.S. Food and Drug Administration approved Bayer's asundexian tablets, brand name Sunharbo, as an adjunct to antiplatelet therapy to reduce the risk of another stroke in adult patients who have recently experienced mild to moderate non-cardioembolic ischemic stroke or high-risk transient ischemic attack (TIA). TIAs are often referred to as "mini strokes"; this approval is for secondary prevention after stroke and does not apply to all people, nor does it include stroke prevention in patients with atrial fibrillation.
Sunharbo is taken orally once daily at a dose of 50 mg. It is the world's first approved activated coagulation factor XI (FXIa) inhibitor. It targets FXIa in the coagulation pathway, rather than factor Xa, which is the action of some existing anticoagulants. Researchers hope to reduce the risk of vascular blockage by inhibiting pathological thrombosis while minimizing the impact on the hemostasis process.
FDA approval is based on the global phase III OCEANIC-STROKE trial. The study included 12,327 patients who were randomly assigned within 72 hours of stroke or high-risk TIA to receive asundexian or placebo in addition to their original single-agent or dual antiplatelet therapy. Results published in the New England Journal of Medicine showed that at a median follow-up of 19 months, 6.2% of the asundexian group developed ischemic stroke compared with 8.4% of the placebo group, a relative risk reduction of 26%. The FDA announcement noted that the median treatment time was 14.2 months.
The overall incidence of severe bleeding in the two groups in the trial was similar, 1.9% and 1.7% respectively. However, the FDA reminded that the risk of severe bleeding increased in the Sunharbo group in patients over 75 years old and within the first 90 days of treatment; gastrointestinal bleeding was also more common, and diarrhea was one of the more commonly reported adverse reactions. It is not recommended for use in patients with moderate or severe hepatic impairment, and is not suitable for patients with atrial fibrillation. It is also not recommended for combined use with certain drugs that affect both P-gp and strong CYP3A4. Medication should be stopped at least 24 hours before elective surgery or invasive procedures, and at least 24 hours after thrombolytic therapy.
Bayer said that approximately one in five patients with a non-cardioembolic ischemic stroke will have another stroke within five years; approximately 795,000 people in the United States have a stroke each year. Sunharbo has been approved by China's National Medical Products Administration, and applications for other markets are still under review, the company said.
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