GSK files first NDA for daprodustat, in Japan

UK pharma major GlaxoSmithKline (LSE: GSK) has made its first marketing authorization application for its daprodustat with the Japanese regulator the Ministry of Health, Labor and Welfare, seeking approval of oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for the treatment of patients with renal anemia due to chronic kidney disease (CKD).

Dr Hal Barron, chief scientific officer and president R&D, GSK said: “Around 3.5 million patients in Japan have anaemia associated with renal disease which can result in weakness and fatigue. We are excited about our first regulatory filing for daprodustat which, if approved, will provide a new and convenient oral treatment option for these patients.”

The filing for daprodustat is primarily based on positive data from the Phase III program conducted in Japan. The studies evaluated daprodustat for the treatment of anemia in patients across the spectrum of CKD from stages 3-5. This included patients on dialysis and those not on dialysis, regardless of prior anemia treatment with erythropoiesis-stimulating agents (ESAs).