Positive Results Move Anemia Contender Enarodustat Towards First Filing

Japanese firms unveil pivotal top-line results that pave way for first filing of novel anemia therapy within new class of agents, but competition is high and timings remain unclear.

Human kidney on scientific background. 3d illustration
JT/Torii's Enarodustat Moves Towards First Filing • Source: Shutterstock

Japanese firm Torii Pharmaceutical Co. Ltd. and parent Japan Tobacco Inc. (JT) are planning a marketing authorization filing in Japan for their oral inhibitor of hypoxia inducible factor-prolyl hydroxylase (HIF-PH), following positive results in comparative Phase III trials.

The new top-line results came from two pivotal studies conducted in Japan with enarodustat (JTZ-951) in either anemic patients with non-dialysis-dependent chronic kidney disease (CKD) or with hemodialysis-dependent CKD and...

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