Bayer has secured US FDA marketing approval for Sunharbo (asundexian), tablets, marking a major milestone in stroke prevention. 

 

The drug is the world's first approved Factor XIa (FXIa) inhibitor and is indicated, in combination with antiplatelet therapy, to reduce the risk of stroke in adults who have recently experienced a non-cardioembolic ischemic stroke (National Institutes of Health Stroke Scale ≤15) or a high-risk transient ischemic attack (TIA).

 

The approval introduces a new treatment option for secondary stroke prevention, a critical area of care aimed at preventing another potentially life-threatening stroke after an initial event.

 

“For those who survive a stroke, the risk of another potentially devastating event is highest in the days and weeks after the initial event, and that risk persists over time,” said Ashkan Shoamanesh, Co-principal Investigator of the OCEANIC-STROKE clinical study and Senior Scientist at Population Health Research Institute, a Joint Institute of Hamilton Health Sciences and McMaster University, Ontario, Canada. 

 

“I believe asundexian introduces an important new addition to post-stroke care that can be used to help patients reduce the risk of a secondary stroke.”

 

Stroke remains one of the world's most pressing public health challenges, affecting approximately 12 million people globally every year, including 795,000 in the United States. It is the world's second leading cause of death and third leading cause of death and disability combined.

 

For survivors and their families, preventing another stroke remains a priority, often considered as important as preventing death.

 

Bayer said the FDA approval is supported by clinical evidence from its Phase III OCEANIC-STROKE trial, which demonstrated the potential of asundexian to address an important gap in secondary stroke prevention.

 

“This FDA approval represents a bold step forward in post-stroke care and is based on compelling clinical evidence from our successfully completed OCEANIC-STROKE study. Asundexian is the first drug approved in a new class of Factor XIa inhibitors worldwide,” said Christian Rommel, Global Head of Research and Development at Bayer`s Pharmaceuticals Division. 

 

“Stroke requires substantial healthcare resource utilization and presents a significant economic and personal burden. At Bayer, our priority is advancing innovations like asundexian to help close gaps in care and reduce the burden of secondary stroke.”

 

The company said the treatment could help address the continuing burden of recurrent stroke while expanding available options for patients at risk of another cerebrovascular event.