Bayer has cleared a major regulatory step in China after the Center of Drug Evaluation (CDE) accepted its marketing authorization application for asundexian, a potential new treatment aimed at preventing ischemic stroke. 

 

The move comes as China continues to face an overwhelming stroke burden. Stroke is the second-leading cause of death and the third-leading cause of disability worldwide, but in China it is the leading cause of both death and disability.

 

"The authorization application marks a significant milestone in our efforts to advance secondary stroke prevention in China, where the burden of stroke is substantial and a need for additional options in secondary stroke prevention remains,” said Christian Rommel, Global Head of Research and Development, Bayer Pharmaceuticals.

 

The filing is backed by results from the Phase III OCEANIC-STROKE study. 

 

According to Bayer, asundexian reduced ischemic stroke risk by 26 percent versus placebo when used alongside antiplatelet therapy in patients after non-cardioembolic ischemic stroke or high-risk TIA. Importantly, the study reported no increase in International Society on Thrombosis and Hemostasis (ISTH) major bleeding.

 

The benefit was consistent across patient groups, including differences in age, sex, stroke or TIA type, stroke subtype, NIHSS score, and treatment approach, whether patients received thrombolysis or standard single or dual antiplatelet therapy.