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Drugs. 2020 Sep;80(13):1365-1371. doi: 10.1007/s40265-020-01383-z.
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.
瓦达昔汀（VAFSEO）是一种脯氨酰羟化酶抑制剂，由 Akebia Therapeutics, Inc.（Akebia）研发，用于治疗与慢性肾脏病（CKD）相关的贫血。Akebia 与 Mitsubishi Tanabe Pharma Corporation 合作在日本开发和商业化瓦达昔汀，并与大冢制药有限公司在 USA、EU 和某些其他地区合作开发和商业化瓦达昔汀。该药在日本获批用于治疗与 CKD 相关的成年患者贫血，正在 USA 和 EU 进行监管申报。本文总结了导致该药首次获批的瓦达昔汀研发的重要里程碑。
