Bayer has secured a landmark regulatory milestone in stroke prevention, with China’s National Medical Products Administration (NMPA) granting marketing authorization for asundexian, branded as Sunharbo. 

 

The once-daily, oral Factor XIa (FXIa) inhibitor, available at a dose of 50 mg, is indicated to reduce the risk of stroke in adults following a non-cardioembolic ischemic stroke or high-risk transient ischemic attack (TIA).

 

The approval makes Sunharbo the first Factor XIa inhibitor approved worldwide, positioning asundexian as a new approach to secondary stroke prevention in a patient population that remains at significant risk of recurrent events.

 

“With the approval of asundexian, we have reached an important milestone and are proud soon to be able to offer physicians in China a new treatment option for stroke survivors after a non-cardioembolic ischemic stroke or high‑risk transient ischemic attack. This enables us to address an unmet need with limited therapeutic advances over the past two decades," said Christian Rommel, Global Head of Research and Development at Bayer`s Pharmaceuticals Division. 

 

"We are working with stakeholders and medical communities to support equitable and timely access for eligible patients in China."

 

The NMPA approval is supported by positive results from the pivotal global Phase III OCEANIC-STROKE study, which evaluated asundexian alongside dual antiplatelet therapy (DAPT) or single antiplatelet therapy (SAPT) in patients following a non-cardioembolic ischemic stroke or high-risk TIA.

 

The trial demonstrated that adding asundexian 50 mg to standard antiplatelet therapy significantly reduced ischemic stroke compared with DAPT or SAPT alone, while the incidence of all bleeding events was similar between the treatment groups.

 

According to Bayer, OCEANIC-STROKE is the first successfully completed Phase III study of an FXIa inhibitor in combination with DAPT or SAPT to demonstrate superiority in reducing ischemic stroke compared with antiplatelet therapy alone.