The European Medicines Agency (EMA) has validated Bayer’s marketing authorisation application for asundexian, an oral Factor XIa inhibitor, to prevent ischaemic stroke.<\/p>\n
EMA has now begun reviewing its use in adults following a non-cardioembolic ischaemic stroke or a high-risk transient ischaemic attack (TIA).<\/p>\n
The validation confirms the application is complete and initiates the EMA\u2019s centralised procedure.<\/p>\n
Bayer continues regulatory submissions for asundexian to other agencies, with priority review recently granted by China\u2019s Center of Drug Evaluation and the US Food and Drug Administration (FDA).<\/p>\n
The application is supported by data from the Phase III international, multi-centre, placebo-controlled, double-blind, randomised OCEANIC-STROKE study.<\/p>\n
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.<\/p>\n
Its primary efficacy endpoint measured time to ischaemic stroke while the primary safety endpoint was International Society on Thrombosis and Hemostasis (ISTH) major bleeding.<\/p>\n
Results published in The New England Journal of Medicine found that asundexian reduced ischaemic stroke by 26% without increasing ISTH major bleeding.<\/p>\n
Asundexian is an investigational compound not yet approved in any country.<\/p>\n
Bayer Pharmaceuticals global research and development head Christian Rommel said: \u201cBetween 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.<\/p>\n
\u201cThe acceptance of our marketing authorisation application by the EMA is a testament to our unwavering commitment to offering patients in need novel treatment options.\u201d<\/p>\n
In June 2025, Bayer subsidiary Vividion Therapeutics secured exclusive worldwide rights<\/a> to develop and commercialise VVD-214, the Werner helicase covalent inhibitor, enhancing its oncology pipeline.<\/p>\n