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Otsuka Pharmaceutical Co., Ltd. (Otsuka) and Akebia T1xbet 신청rapeutics, Inc. (Akebia) announce　that t1xbet 신청 U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Akebia's New Drug Application (NDA) for Akebia's vadadustat, an investigational oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor under review for t1xbet 신청 treatment of anemia due to chronic kidney disease (CKD). T1xbet 신청 FDA issues CRLs to indicate that t1xbet 신청 review cycle for an application is complete and that t1xbet 신청 application is not ready for approval in its present form.

Akebia and Otsuka will review t1xbet 신청 CRL closely and consider t1xbet 신청 future direction.

In October 2021, Otsuka, in collaboration with Akebia, submitted an initial marketing authorization application (MAA) to t1xbet 신청 European Medicines Agency (EMA) for vadadustat, for t1xbet 신청 treatment of anemia associated with CKD in adults. T1xbet 신청 review is ongoing.