German life sciences giant Bayer has announced a key regulatory milestone for its experimental stroke-prevention drug.

 

This,vas the European Medicines Agency (EMA) has positively validated and officially begun reviewing the company’s marketing authorization application for asundexian, an oral Factor XIa (FXIa) inhibitor designed to reduce the risk of ischemic stroke in patients.

 

The validation confirms the submission is complete, clearing the way for the EMA’s centralized review process to formally evaluate the therapy.

 

The application targets adults who have previously experienced a non-cardioembolic ischemic stroke or a high-risk transient ischemic attack (TIA), a population facing significant risk of recurrence.

 

Stroke remains one of the most pressing global health challenges, and is the second leading cause of death worldwide and across Europe, with an estimated global economic burden of 891 billion US dollars annually.

 

Christian Rommel, Global Head of Research and Development at Bayers Pharmaceuticals Division, said: “Between 2010 and 2019, the prevalence of ischemic stroke and stroke-related mortality increased by 4 percent and 7 percent, respectively, across EU member states underscoring the growing burden of this disease."

 

“The acceptance of our marketing authorization application by the EMA is a testament to our unwavering commitment to offering patients in need novel treatment options.”

 

Bayer is also pushing forward with global regulatory submissions. The company noted that China’s Center of Drug Evaluation and the U.S. Food and Drug Administration (FDA) have both recently granted asundexian Priority Review designation, underscoring international interest in the therapy’s potential.