EMA validates Bayer's asundexian application for ischaemic stroke

The EMA has validated Bayer's marketing authorisation application for asundexian, an oral Factor XIa inhibitor, to prevent ischaemic stroke. The application is supported by data from the Phase III OCEANIC-STROKE study. The study compared asundexian 50mg plus antiplatelet therapy to placebo in post-ischaemic stroke or high-risk TIA patients. Credit: Jo Panuwat D / Shutterstock.com. 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). LOA and PTSR…

Source: Pharmaceutical Technology