Bayer has filed Asundexian for secondary stroke prevention in China after Phase III OCEANIC-STROKE data showed a 26% reduction in ischemic stroke risk 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 (NMPA) has accepted its marketing authorization application for Asundexian.
The application seeks approval for the prevention of ischemic stroke in patients following a non-cardioembolic ischemic stroke or high-risk transient ischemic attack (TIA).
Bayer stated that the application marks a step toward expanding treatment options for secondary stroke prevention in China, where unmet clinical need remains high.
The submission is supported by results from the Phase III OCEANIC-STROKE trial (NCT05686070). The study evaluated Asundexian 50 mg once daily in combination with antiplatelet therapy in patients after a non-cardioembolic ischemic stroke or high-risk TIA.
The trial enrolled 12,327 participants globally and used a randomized, double-blind, placebo-controlled design.
Results showed that Asundexian reduced the risk of ischemic stroke by 26% compared with placebo when added to antiplatelet therapy. The reduction was observed without an increase in major bleeding, as defined by the International Society on Thrombosis and Hemostasis (ISTH). The treatment effect was consistent across subgroups, including age, sex, stroke subtype, and background therapies.
Findings from the OCEANIC-STROKE study were recently published in The New England Journal of Medicine.
Asundexian is an oral Factor XIa (FXIa) inhibitor. FXIa plays a role in thrombosis by contributing to clot formation and vessel blockage, while having a limited role in normal hemostasis. This mechanism may allow anticoagulation with a lower risk of bleeding, although the drug remains investigational and is not yet approved in any country.
Stroke remains a major global health burden, ranking as the second-leading cause of death and the third-leading cause of disability worldwide. In China, it is the leading cause of both death and disability. The prevalence of ischemic stroke in China rose by 10% between 2010 and 2021, reaching 20.8 million cases.
Recurrent ischemic strokes are associated with higher mortality and greater disability compared to first events. Bayer is continuing to submit regulatory applications for Asundexian in multiple regions as part of its broader cardiovascular and cerebrovascular development program.
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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.