EMA Begins Review of Bayer’s Asundexian for Secondary Stroke Prevention

Bayer has cleared an important regulatory milestone for asundexian after the European Medicines Agency (EMA) validated and accepted the company’s marketing authorization application for review. The submission seeks approval of the oral Factor XIa inhibitor for the prevention of ischemic stroke in adults who have experienced a non-cardioembolic ischemic stroke or a high-risk transient ischemic attack (TIA).

EMA validation confirms the application is complete and initiates the agency’s centralized assessment process. The filing is supported by results from the pivotal Phase 3 OCEANIC-STROKE trial (NCT05686070), which demonstrated a significant reduction in recurrent ischemic stroke when asundexian was added to standard antiplatelet therapy.

A Novel Approach to Stroke Prevention

Stroke remains one of the leading causes of death and long-term disability worldwide. In Europe alone, approximately 10 million people live with the consequences of stroke, while more than one million new cases occur each year. The growing clinical and economic burden continues to drive demand for therapies that improve prevention without increasing bleeding risk.

Asundexian targets activated Factor XI (FXIa), a key component of the coagulation cascade involved in pathological clot formation. Unlike conventional anticoagulants that affect broader clotting mechanisms, FXIa inhibition aims to reduce thrombosis while preserving normal hemostasis. This approach has attracted significant interest as a potential strategy to lower thrombotic events with a more favorable bleeding profile.

Phase 3 OCEANIC-STROKE Results

The EMA application is based on data from the global Phase 3 OCEANIC-STROKE study, which enrolled 12,327 patients following a non-cardioembolic ischemic stroke or high-risk TIA.

The randomized, double-blind, placebo-controlled trial evaluated once-daily asundexian 50 mg plus antiplatelet therapy versus placebo plus antiplatelet therapy. The primary efficacy endpoint was time to ischemic stroke, while the primary safety endpoint assessed major bleeding according to International Society on Thrombosis and Hemostasis (ISTH) criteria.

Results showed that asundexian reduced the risk of ischemic stroke by 26% compared with placebo. The treatment did not increase the incidence of ISTH major bleeding, addressing a longstanding challenge in secondary stroke prevention. Full findings from the study have been published in The New England Journal of Medicine.

Regulatory Momentum Builds

Commenting on the milestone, Christian Rommel, Ph.D., Global Head of Research and Development at Bayer’s Pharmaceuticals Division, noted that rising rates of ischemic stroke and stroke-related mortality across European Union member states underscore the need for new treatment options. He said the EMA’s acceptance of the application reflects the company’s continued focus on advancing innovative therapies for patients at risk of recurrent stroke.

Bayer is also pursuing approvals in other major markets. Regulatory submissions are under review globally, while both the U.S. Food and Drug Administration and China’s Center for Drug Evaluation have granted Priority Review designation to asundexian.

If approved, asundexian could become one of the first Factor XIa inhibitors available for secondary prevention of ischemic stroke, potentially introducing a new treatment option that balances thrombotic protection with bleeding safety.

Reference

European Medicines Agency confirms Asundexian marketing authorization application for assessment in secondary prevention of ischemic stroke