GlaxoSmithKline PLC secured the first regulatory approval for Duvroq as Japan's regulator gave it the go-ahead to treat chronic kidney disease-associated anemia.

Duvroq, or daprodustat, will be exclusively distributed nationwide by Tokyo-based Kyowa Kirin Co. Ltd. following a 2018 deal.

The decision comes less than a year after GSK filed a new drug application with Japan's Ministry of Health, Labor and Welfare.

Duvroq can now be used as an oral treatment option for renal anemia, which is common in patients with chronic kidney disease. The condition is caused by inadequate production of a hormone, erythropoietin, needed to produce red blood cells.

Japan has an estimated 3.5 million patients with chronic kidney disease-associated anemia, Hal Barron, GSK's chief scientific officer, noted in a June 29 news release.

The British pharmaceutical giant plans to seek regulatory approval for the tablets in other countries based on an ongoing global phase 3 program comprising studies dubbed ASCEND-D and ASCEND-ND, which will assess dialysis-dependent and non-dialysis dependent patients diagnosed with renal disease-associated anemia.

The tablets belong to a class of drugs called hypoxia-inducible factor prolyl hydroxylase inhibitors, which trigger the body's adaptation to oxygen deprivation and encourage bone marrow to produce red blood cells.