Bayer's asundexian Phase III study to be expanded

7 November 2023

German pharma major Bayer (BAYN: DE) has revealed it is expanding its Phase III OCEANIC clinical development program for the investigational drug asundexain (BAY2433334) by initiating a third clinical study, OCEANIC-AFINA.

At the JP Morgan Healthcare Conference early this year, Bayer forecast that its once-daily asundexian could exceed 5 billion euros ($5.4 billion) in peak revenues. Also, GlobalData believes that the drug will be a significant driver of growth of the Factor XI (FXI) and FXIa inhibitors.

OCEANIC-AFINA is a Phase III study investigating asundexian as a potential treatment option in patients (≥65 years of age) with atrial fibrillation (AF) at high risk for ischemic stroke or systemic embolism who are deemed ineligible for oral anticoagulation (OAC) treatment due to reasons such as an increased risk of bleeding. OCEANIC-AFINA complements OCEANIC-AF, an ongoing Phase III study investigating the efficacy and safety profile of asundexian for the prevention of stroke or systemic embolism in people with AF at risk of stroke.

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