EMA Begins Review of Bayer’s Stroke Drug Asundexian
Bayer has reached an important regulatory milestone for its investigational stroke prevention therapy as the European Medicines Agency (EMA) has validated and begun reviewing the company’s marketing authorization application for asundexian, an oral Factor XIa (FXIa) inhibitor designed to reduce the risk of recurrent ischemic stroke.
The application seeks approval of asundexian for the prevention of ischemic stroke in adults who have previously experienced a non-cardioembolic ischemic stroke or a high-risk transient ischemic attack (TIA), often referred to as a “mini-stroke.” Validation of the submission confirms that the application package is complete and allows the EMA’s centralized scientific review process to officially commence.
The development comes at a time when stroke continues to represent a major public health challenge across Europe and worldwide. According to Bayer, approximately 10 million people in Europe are currently living with the consequences of stroke, while more than one million new cases occur each year. Stroke remains the second leading cause of death globally and across Europe, creating a substantial burden on healthcare systems and society. Global costs associated with stroke are estimated to reach approximately $891 billion annually.
Asundexian belongs to a new class of anticoagulant therapies targeting Factor XIa, a key component of the blood-clotting pathway. Researchers believe that inhibiting Factor XIa may help reduce the risk of clot-related events such as ischemic stroke while potentially lowering bleeding risks compared with traditional anticoagulant therapies. This mechanism has attracted significant attention from the pharmaceutical industry as companies seek safer and more effective options for preventing recurrent cardiovascular and cerebrovascular events.
Christian Rommel, Global Head of Research and Development at Bayer’s Pharmaceuticals Division, highlighted the growing impact of stroke across Europe and emphasized the need for innovative treatment approaches. He noted that between 2010 and 2019, the prevalence of ischemic stroke increased by 4% across European Union member states, while stroke-related mortality rose by 7%, underscoring the escalating healthcare burden posed by the disease.
Rommel said the EMA’s acceptance of the application reflects Bayer’s commitment to developing new therapies for patients at risk of recurrent stroke and other serious thrombotic conditions. The company views the regulatory review as a significant step toward potentially expanding treatment options for patients who remain vulnerable to future cerebrovascular events despite existing standards of care.
The European filing is part of Bayer’s broader global regulatory strategy for asundexian. The company is actively pursuing approvals in multiple regions and has already received encouraging feedback from other major health authorities. Recently, both China’s Center for Drug Evaluation and the U.S. Food and Drug Administration (FDA) granted Priority Review designation to regulatory submissions involving asundexian, highlighting the potential importance of the therapy in addressing unmet medical needs.
If approved, asundexian could become one of the first Factor XIa inhibitors available for stroke prevention, representing a potentially significant advancement in anticoagulation therapy. The EMA’s review process will now evaluate the drug’s efficacy, safety, and overall benefit-risk profile before reaching a final decision.
For Bayer, the review marks another milestone in its efforts to strengthen its cardiovascular portfolio and address one of the world’s leading causes of disability and death. The outcome of regulatory reviews in Europe, the United States, and China will be closely watched by physicians, patients, and investors alike as the race to bring next-generation anticoagulant therapies to market continues.