Abstract
Vadadustat (VAFSEO®) is a prolyl hydroxylase inhibitor being developed by Akebia Therapeutics, Inc. (Akebia) for the treatment of anaemia associated with chronic kidney disease (CKD). Akebia is collaborating with Mitsubishi Tanabe Pharma Corporation on the development and commercialization of vadadustat in Japan and with Otsuka Pharmaceutical Co. Ltd on the development and commercialization of vadadustat in the USA, the EU and certain other territories. The drug is approved in Japan for use in adult patients with anaemia associated with CKD and regulatory submissions are planned in the USA and the EU. This article summarizes the milestones in the development of vadadustat leading to this first approval.
Publication types
-
Historical Article
-
Review
MeSH terms
-
Adult
-
Anemia / drug therapy*
-
Anemia / etiology
-
Clinical Trials as Topic / history
-
Drug Approval / history*
-
Drug Approval / legislation & jurisprudence
-
Drug Approval / statistics & numerical data
-
Drug Development / history*
-
Drug Development / legislation & jurisprudence
-
Glycine / analogs & derivatives*
-
Glycine / history
-
Glycine / pharmacology
-
Glycine / therapeutic use
-
History, 21st Century
-
Humans
-
Japan
-
Picolinic Acids / history
-
Picolinic Acids / pharmacology
-
Picolinic Acids / therapeutic use*
-
Prolyl-Hydroxylase Inhibitors / history
-
Prolyl-Hydroxylase Inhibitors / pharmacology
-
Prolyl-Hydroxylase Inhibitors / therapeutic use*
-
Renal Insufficiency, Chronic / blood
-
Renal Insufficiency, Chronic / complications
-
United States
Substances
-
Picolinic Acids
-
Prolyl-Hydroxylase Inhibitors
-
vadadustat
-
Glycine