The European Medicines Agency (EMA) accepted Bayer’s marketing authorization application for asundexian. This validation confirms the submission is complete and initiates the centralized review process. Asundexian is an oral Factor XIa inhibitor designed for the secondary prevention of ischemic stroke in adults.
This submission marks the first time a Factor XIa inhibitor has undergone regulatory review in Europe. Data from the pivotal Phase III OCEANIC-STROKE study supports the application. The trial demonstrated that asundexian significantly reduced ischemic stroke risk compared to a placebo. The drug achieved this reduction without increasing the risk of major bleeding.
The review is a critical development for Bayer’s pharmaceutical pipeline following a previous trial halt for asundexian in atrial fibrillation. Regulatory bodies in the U.S. and China have already granted the drug priority review designations. Stroke currently ranks as the second leading cause of death in Europe.