Bayer has announced that the US Food and Drug Administration (FDA) and Japan’s Ministry of Health, Labour and Welfare have accepted the company’s New Drug Applications (NDA) for its investigational Factor XIa (FXIa) inhibitor, asundexian, for the prevention of ischemic stroke in patients after a non-cardioembolic ischemic stroke or transient ischemic attack (TIA). In addition, the US FDA granted asundexian priority review designation.
Approximately 12 million people experience a stroke every year. Of those who survive a stroke, approximately 1 in 10 will have another stroke within one year, even with available secondary stroke prevention strategies.
Bayer is continuing to submit applications for marketing authorization for asundexian to other health authorities globally. China’s Center of Drug Evaluation has also recently accepted Bayer’s marketing authorisation application for asundexian and granted it Priority Review designation.
The phase 3 ‘oceanic-stroke’ study investigated the efficacy and safety of the oral Factor XIa inhibitor asundexian 50 mg once-daily compared to placebo, for prevention of ischemic stroke in patients after a non-cardioembolic ischemic stroke or high-risk transient ischemic attack (TIA) in combination with antiplatelet therapy.
It is a multicentre, international, randomised, placebo-controlled, double-blind, parallel group and event-driven study, that randomised 12,327 participants worldwide. The primary efficacy endpoint was time to ischemic stroke; the primary safety endpoint was ISTH major bleeding. The full results from oceanic-stroke have recently been published in The New England Journal of Medicine.
The applications to the US FDA and to Japan’s Ministry of Health, Labour and Welfare are based on positive data from the study. The study found that asundexian 50 mg, significantly reduced ischemic stroke by 26% in patients after a non-cardioembolic ischemic stroke or high-risk TIA compared to placebo, both in combination with antiplatelet therapy, with no increase in ISTH (International Society on Thrombosis and Hemostasis) major bleeding.
