Bayer recently announced that the European Medicines Agency (EMA) has positively validated and begun assessing the company’s Marketing Authorisation Application (MAA) for asundexian, an oral Factor XIa (FXIa) inhibitor, in the prevention of ischemic stroke in adults after a non-cardioembolic ischemic stroke or a high-risk Transient Ischemic Attack (TIA).

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

Christian Rommel, PhD, Global Head of Research and Development—Pharmaceuticals Division, Bayer, said, “Between 2010 and 2019, the prevalence of ischemic stroke and stroke-related mortality increased by 4 percent and 7 percent, 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.”

Bayer is continuing to submit applications for MA for asundexian to other health authorities globally. China’s Center of Drug Evaluation and the US Food and Drug Administration (FDA) have recently granted asundexian Priority Review (PR) designation.