Bayer announced that China’s NMPA has accepted the marketing authorization application for Asundexian, an investigational oral Factor XIa inhibitor for secondary prevention after ischemic stroke or high-risk TIA. The submission is supported by Phase III OCEANIC-STROKE data showing a 26% reduction in ischemic stroke without increased major bleeding.
Written By: Mahathi Palivela, PharmD
Reviewed By: Pharmacally Editorial Team
Bayer announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration has granted Priority Review designation to the company’s marketing authorization application for Asundexian, an investigational oral Factor XIa inhibitor for secondary prevention following ischemic stroke.
China’s Priority Review pathway is intended to accelerate the evaluation of therapies that address urgent clinical needs and may provide significant therapeutic value.
The application covers patients who have experienced a non-cardioembolic ischemic stroke or high-risk transient ischemic attack (TIA). Bayer said the designation marks an important regulatory milestone as stroke remains the leading cause of death and disability in China.
According to the company, the prevalence of ischemic stroke in China increased by 10% between 2010 and 2021 to 20.80 million cases. Stroke is also the second-leading cause of death and the third-leading cause of disability globally. Bayer noted that approximately one in five stroke survivors experiences another stroke within five years, with recurrent ischemic strokes often associated with greater disability and higher mortality risk.
Christian Rommel, Ph.D., Global Head of Research and Development at Bayer Pharmaceuticals, said the Priority Review designation marks a significant step in advancing secondary stroke prevention efforts in China, where the burden of stroke remains substantial and additional treatment options are needed.
The submission is supported by findings from the Phase III OCEANIC-STROKE study, which showed that Asundexian 50 mg significantly reduced ischemic stroke by 26% compared with placebo when added to antiplatelet therapy, without increasing major bleeding risk. Bayer also reported that treatment effects were consistent across key patient subgroups, including age, sex, stroke subtype, NIHSS score, and both single and dual antiplatelet therapy strategies.
Asundexian remains investigational and has not been approved by any health authority worldwide. Bayer said it continues to pursue additional regulatory submissions for the therapy globally.
Reference
China’s Center of Drug Evaluation grants Priority Review designation for Bayer’s FXIa inhibitor
About the Writer
Mahathi Palivela is pursuing PharmD and has a strong interest in Clinical Pharmacy and Patient safety. She is passionate about handling and analyzing patient data, and translating clinical insights into clear, meaningful summaries. She aims to apply this interest in Medical Writing and Pharmacovigilance, focusing on improving patient outcomes through careful data interpretation and communication.