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GSK Submits Daprodustat For Approval In Japan To Treat Renal Anaemia Due To CKD

GlaxoSmithKline plc (GSK.L,GSK) Wednesday announced that it has submitted a Japanese New Drug Application or JNDA to the Ministry of Health, Labour and Welfare seeking marketing approval for daprodustat to treat patients with renal anaemia due to chronic kidney disease or CKD.

Daprodustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor or HIF-PHI. The company noted that HIF-PHIs are a new class of drug that trigger the body's adaptations to hypoxia and encourage the bone marrow to make more red blood cells, thereby benefitting patients with renal anaemia.

GSK said the JNDA for daprodustat is primarily based on positive data from the phase 3 programme conducted in Japan. The studies evaluated daprodustat for the treatment of anaemia in patients across the spectrum of CKD from stages 3-5.

Daprodustat is not approved as a treatment for renal anaemia or any other indication anywhere in the world.

If approved, daprodustat will be exclusively distributed in Japan by Kyowa Kirin Co., Ltd., following the strategic commercialisation deal announced in 2018.

GSK and Kyowa Kirin would jointly conduct launch activities, including engagement of healthcare professionals and commercial activities.

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