en.Wedoany.com Reported - The European Medicines Agency (EMA) has confirmed the acceptance and initiation of the evaluation of the marketing authorization application for Asundexian, an oral Factor XIa (FXIa) inhibitor, for the prevention of ischemic stroke in adult patients with non-cardioembolic ischemic stroke or high-risk transient ischemic attack (TIA).
The EMA’s acceptance confirmation indicates that the application is complete and has initiated the centralized review process. Stroke is becoming an increasingly serious public health challenge: approximately 10 million people in Europe are affected by its sequelae, with over 1 million new cases annually. Globally and within Europe, stroke is the second leading cause of death, with an estimated annual healthcare cost of $891 billion worldwide.
Christian Rommel, Global Head of Research and Development at Bayer’s Pharmaceuticals Division, stated that between 2010 and 2019, the prevalence of ischemic stroke and related mortality rates in all EU member states increased by 4% and 7%, respectively, with the disease burden continuing to rise. The EMA’s acceptance of this marketing authorization application is a recognition of the team’s work. Bayer is submitting marketing authorization applications for Asundexian to other regulatory authorities worldwide. The Center for Drug Evaluation (CDE) of China and the U.S. Food and Drug Administration (FDA) have recently granted priority review status to this drug.
This submission is based on positive data from the Phase III Oceanik-Stroke study. This multicenter, international, randomized, placebo-controlled, double-blind, parallel-group, event-driven trial enrolled 12,327 participants globally. It primarily evaluated the efficacy and safety of oral Factor XIa inhibitor Asundexian 50 mg once daily combined with antiplatelet therapy, compared to placebo combined with antiplatelet therapy, for the prevention of ischemic stroke in patients with non-cardioembolic ischemic stroke or high-risk TIA. The primary efficacy endpoint was time to ischemic stroke; the primary safety endpoint was major bleeding as defined by the International Society on Thrombosis and Haemostasis (ISTH). Study results showed that Asundexian 50 mg combined with antiplatelet therapy reduced ischemic stroke by a significant 26%, with no increase in ISTH-defined major bleeding. Full results have been published in The New England Journal of Medicine.
Factor XIa (FXIa) is a protein in the coagulation pathway that plays different roles in hemostasis and thrombosis. FXIa is believed to be involved in the pathological formation, growth, and vascular occlusion of thrombi, but plays a lesser role in the formation of hemostatic plugs that seal leaks at sites of vascular injury. It should be noted that Asundexian is an investigational compound and has not been approved by health authorities in any country or for any indication.
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