Bayer announced that the Center of Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted Priority Review (PR) designation for the company’s marketing authorisation application for asundexian.

The CDE’s PR pathway is an accelerated regulatory approval process intended for drug candidates that address urgent medical needs and have the potential to provide significant clinical value, if approved.

Christian Rommel, Ph.D., Global Head of Research and Development, Bayer Pharmaceuticals, said, “The Priority Review designation for asundexian marks a pivotal moment in our commitment to combat the rising tide of ischemic strokes. This accelerated pathway brings us closer to delivering new treatment options for millions affected by stroke.”

Bayer is continuing to submit applications for marketing authorisation for asundexian to other health authorities globally.