Otsuka files for EMA approval of vadadustat

1 November 2021

Shares of Otsuka Holdings (TYO: 4578) were up 2.8% at 4,620 yen today, as the Japanese drugmaker announced that its Dutch subsidiary has submitted an initial marketing authorization application (MAA) to the European Medicines Agency for vadadustat, an investigational oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor, for the treatment of anemia associated with chronic kidney disease (CKD) in adults.

Vadadustat was developed in Europe under a collaboration and license agreement between Akebia Therapeutics (Nasdaq: AKBA) and Otsuka Pharmaceutical.

Anemia is a commonly diagnosed complication among patients suffering with chronic kidney disease, and if left untreated, it may affect patient quality of life.

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