Vadadustat: First Approval
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ADISINSIGHT REPORT
Vadadustat: First Approval Anthony Markham1
© Springer Nature Switzerland AG 2020
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.
Vadadustat ( VAFSEO®): Key points A prolyl hydroxylase inhibitor is being developed by Akebia Therapeutics, Inc. for the treatment of anaemia associated with chronic kidney disease Received its first approval on June 29 2020 in Japan Approved for use adult patients with anaemia associated with chronic kidney disease
1 Introduction Vadadustat (VAFSEO®) is an orally active inhibitor of prolyl hydroxylase being developed by Akebia Therapeutics Inc. (Akebia) for the treatment of anaemia associated with chronic kidney disease (CKD) [1]. Inhibition of prolyl Enhanced material for this AdisInsight Report can be found at https://doi.org/10.6084/m9.figshare.12782549. This profile has been extracted and modified from the AdisInsight database. AdisInsight tracks drug development worldwide through the entire development process, from discovery, through preclinical and clinical studies to market launch and beyond. * Anthony Markham [email protected] 1
Springer Nature, Private Bag 65901, Mairangi Bay, Auckland 0754, New Zealand
hydroxylase (PHD) prevents degradation of hypoxia-inducible factor (HIF)-α, leading to increased production of erythropoietin [2]. Anaemia in patients with CKD arises as a result of the diseased kidney being unable to adequately escalate erythropoietin production in response to hypoxia and/or anaemia, and erythropoietin stimulating agents are thus widely used to restore haemoglobin levels [3]. Vadadustat is approved in Japan [4] for the treatment of adult patients with anaemia secondary to CKD [5]. Submission of a new drug application to the US FDA and a marketing authorisation to the EMA are planned soon as possible after the top-line data readout of the phase III PRO2TECT trial program in 2020 [6]. In Japan, the recommended starting dose of vadadustat is 300 mg administered orally once daily, adjusted to within a range of 150–600 mg once daily, according to response [5].
1.1 Company Agreements Akebia was founded in September 2007 [7]. In December 2015, Akebia and Mitsubishi Tanabe Pharma Corporation entered into a development and commercialisation agreement for vadadustat in Japan and certain other countries in Asia, including Taiwan, South Korea, Indonesia and India [1]. In Decemb
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