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GSK files anaemia drug daprodustat in Japan, its first market

Around 3.5 million people in Japan could access the drug


GlaxoSmithKline (GSK)has kicked off its marketing applications for daprodustat, a new oral drug for anaemia associated with chronic kidney disease (CKD), in Japan.

If approved,daprodustat would be an oral alternative to erythropoiesis-stimulating agents (ESAs) such as Kyowa Kirin’s Espo (epoetin alfa) and biosimilars that have to be delivered by injection. Anaemia in CKD is caused by a deficiency in erythropoietin, a hormone involved in prompting the production of red blood cells.

Daprodustat – a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) – will be distributed in Japan by Kyowa Kirin if it gets the nod from the Ministry of Health, Labour and Welfare (MHLW), allowing GSK to piggyback on the Japanese company’s established ESA expertise. Elsewhere, daprodustat is in phase 3 testing.

Hal Barron

Hal Barron, chief scientific officer, GSK

GSK chief scientific officer Hal Barron said there are around 3.5 million people in Japan with anaemia related to CKD, which “can result in weakness and fatigue”.

Another oral HIF-PHI drug – AstraZeneca and FibroGen’s roxadustat– has already been approved in China for CKD anaemia.Additional competition could come from Akebia, which has a drug in the class called vadadustat in late-stage clinical testing that is licensed to Mitsubishi Tanabe Pharma in some Asian markets including Japan.

Astellas Pharma meanwhile has rights to roxadustat in Japan and Europe and has phase 3 trials on the go in those territories.

ESAs directly stimulate red blood cell production but can cause blood clots and other cardiovascular side effects. In contrast, HIF-PHI drugs stimulate endogenous production of erythropoietin, and their developers think this mechanism leads to lower but more consistent EPO levels in the blood, thus avoiding complications.

There are other advantages to oral therapy. Ease of administration is one– unlike ESAs, HIF-PHIs do not need to be kept in cold storage, and analysts have suggested the new drugs could eventually generate several billions of dollars in sales.

GSK’s clinical trials programme for daprodustat outside Japan includes two pivotal studies, namely ASCEND-D in people with CKD-related anaemiawho require dialysis and ASCEND-ND which involves non-dialysis patients.

In both trials patients will switch to daprodustat from their ESA therapy, while ASCEND-ND will also enrol previously-untreated individuals.

Article by
Phil Taylor

21st August 2019

From: Regulatory



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