The European Medicines Agency (EMA) has validated Bayer’s marketing authorisation application for asundexian, an oral Factor XIa inhibitor, to prevent ischaemic stroke.
EMA has now begun reviewing its use in adults following a non-cardioembolic ischaemic stroke or a high-risk transient ischaemic attack (TIA).
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The validation confirms the application is complete and initiates the EMA’s centralised procedure.
Bayer continues regulatory submissions for asundexian to other agencies, with priority review recently granted by China’s Center of Drug Evaluation and the US Food and Drug Administration (FDA).
The application is supported by data from the Phase III international, multi-centre, placebo-controlled, double-blind, randomised OCEANIC-STROKE study.
The trial randomised 12,327 participants worldwide. It compared asundexian 50mg once-daily plus antiplatelet therapy to placebo and antiplatelet therapy in patients following non-cardioembolic ischaemic stroke or high-risk TIA.
Its primary efficacy endpoint measured time to ischaemic stroke while the primary safety endpoint was International Society on Thrombosis and Hemostasis (ISTH) major bleeding.
Results published in The New England Journal of Medicine found that asundexian reduced ischaemic stroke by 26% without increasing ISTH major bleeding.
Asundexian is an investigational compound not yet approved in any country.
Bayer Pharmaceuticals global research and development head Christian Rommel said: “Between 2010 and 2019, the prevalence of ischaemic stroke and stroke-related mortality increased by 4% and 7%, respectively, across EU member states, underscoring the growing burden of this disease.
“The acceptance of our marketing authorisation application by the EMA is a testament to our unwavering commitment to offering patients in need novel treatment options.”
In June 2025, Bayer subsidiary Vividion Therapeutics secured exclusive worldwide rights to develop and commercialise VVD-214, the Werner helicase covalent inhibitor, enhancing its oncology pipeline.
