Bayer recently announced that the Center of Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted the company’s marketing authorisation application for asundexian as a treatment for the prevention of ischemic stroke in patients after a non-cardioembolic ischemic stroke or Transient Ischemic Attack (TIA).

“The acceptance of our marketing authorisation 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, Ph.D., Global Head of Research and Development, Bayer Pharmaceuticals.

The marketing authorisation application to the CDE is based on positive data from the phase 3 OCEANIC-STROKE study, which showed that asundexian significantly reduced ischemic stroke by 26 percent compared to placebo, both in combination with antiplatelet therapy, in patients after a non-cardioembolic ischemic stroke or high-risk TIA, with no increase in International Society on Thrombosis and Hemostasis (ISTH) major bleeding. These findings were consistent regardless of age or sex, index event (stroke or high-risk TIA), stroke subtype, National Institutes of Health Stroke Scale (NIHSS) and acute stroke therapy like thrombolysis or planned secondary prevention strategies (single or dual anti-platelet therapy).

Bayer is continuing to submit applications for marketing authorisations of asundexian to health authorities globally.