Otsuka Applies to EMA for Marketing Authorization of Vadadustat

Otsuka has submitted an initial marketing authorization application to EMA for vadadustat as a treatment of anemia associated with CKD in adults.

Otsuka Pharmaceutical Europe has announced, in an Oct. 29, 2021 press release, that Otsuka Pharmaceutical Netherlands has submitted an initial marketing authorization application to the European Medicines Agency (EMA) for vadadustat.

Vadadustat is an investigational oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor aimed at the treatment of anemia associated with chronic kidney disease (CKD) in adults. The therapy was developed under a collaboration and license agreement with Akebia Therapeutics.

“We are excited to reach this regulatory milestone in collaboration with Akebia, demonstrating our continued commitment to patients with chronic kidney disease” said Andy Hodge, CEO of Otsuka Pharmaceutical Europe Ltd. and Otsuka Pharmaceutical Development and Commercialization Europe GmbH, in the press release.

Source: Otsuka Pharmaceuticals