EMA confirms asundexian marketing authorization application for assessment in secondary prevention of ischemic stroke

Bayer

10 June 2026 - Bayer today announced that the EMA has positively validated and begun assessing the company’s marketing authorisation application for asundexian, an oral factor XIa inhibitor, in the prevention of ischemic stroke in adults after a non-cardioembolic ischemic stroke or a high-risk transient ischemic attack.

Validation of the application confirms the submission is complete and begins the EMA’s centralised review procedure.

Read Bayer press release

Michael Wonder

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Michael Wonder

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Medicine , Europe , Dossier , Registration