GlaxoSmithKline PLC said it is seeking approval from Japan's regulator for its drug to treat chronic kidney disease-associated anemia.
Daprodustat treats renal anemia. The condition is common in chronic kidney disease, in which the organs fail to produce enough of a hormone, erythropoietin, needed to produce red blood cells.
The U.K. pharma giant submitted the Japanese new drug application to the Ministry of Health, Labor and Welfare. Hal Barron, GSK's chief scientific officer, noted in the Aug. 21 news release that about 3.5 million patients in Japan have anemia associated with renal disease.
Daprodustat, an oral drug, triggers the body's adaptations to hypoxia, or oxygen deprivation, and encourages the bone marrow to make more red blood cells. It is one of a class of drugs known as hypoxia-inducible factor prolyl hydroxylase inhibitors.
The approval request is based on positive data from a phase 3 clinical trial conducted in Japan.
Daprodustat is not approved to treat renal anemia anywhere in the world. If approved in Japan, it would be exclusively distributed in the country by Kyowa Kirin Co. Ltd., following a 2018 commercialization deal.
