India, Oct. 26 -- Bayer said China's National Medical Products Administration (NMPA) has approved Asundexian 50 mg, marketed as Sunharbo, to reduce the risk of stroke in adults who have experienced a non- cardioembolic ischemic stroke or high-risk transient ischemic attack (TIA), often called a 'mini-stroke'. The approval makes Asundexian the first Factor Xia (FXIa) inhibitor approved worldwide.
Stroke is the leading cause of death and disability in China, and many patients remain at risk of experiencing another stroke even after receiving standard prevention treatments.
The approval was granted following a priority review and was supported by results from the global Phase 3 OCEANIC STROKE study, which enrolled more than 12,000 patients w...