GSK's Chronic Kidney Disease Anemia Drug Daprodustat Receives First Global Approval in Japan

Source: Jike Yaowen

On June 29, GlaxoSmithKline (GSK) announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) had approved a New Drug Application (NDA) in Japan for Duvroq (daprodstat) tablets. This drug is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) indicated for the treatment of anemia in patients with chronic kidney disease (CKD). This approval marks a significant step forward in GSK’s global efforts to support patients with anemia associated with chronic kidney disease (CKD).

This New Drug Application (NDA) is primarily based on positive data from Phase 3 clinical programs conducted in Japan. These studies evaluated Duvroq for the treatment of anemia in patients with Stage 3–5 chronic kidney disease (CKD), including both dialysis-dependent patients (hemodialysis and peritoneal dialysis) and non-dialysis-dependent patients, regardless of prior treatment with erythropoiesis-stimulating agents (ESAs). Compared with current standard injectable therapies, Duvroq offers the convenience of oral administration and the flexibility of once-daily dosing for both dialysis and non-dialysis patients. The three Phase 3 clinical studies conducted in Japan included: a 52-week study in 271 hemodialysis patients previously treated with ESAs, comparing daprodustat with darbepoetin alfa; a 52-week study in 299 patients with Stage 3–5 CKD not on dialysis, who were either ESA-naïve or previously treated with ESAs, comparing daprodustat with the long-acting ESA epoetin beta pegol, which also included a cohort of 56 peritoneal dialysis patients, all of whom received daprodustat; and a 24-week, open-label study in 28 ESA-naïve hemodialysis patients treated with daprodustat.

Dr. Hal Barron, Chief Scientific Officer and President of Research and Development at GSK, stated: “The approval of Duvroq provides a new, convenient oral treatment option for nearly 3.5 million patients in Japan suffering from anemia associated with kidney disease. We are pleased with this initial approval and look forward to sharing data from our ongoing Phase 3 clinical programs as we strive to help more patients worldwide affected by this condition.”

Anemia Caused by Chronic Kidney Disease

Anemia caused by chronic kidney disease is common in patients with renal impairment because the kidneys no longer produce sufficient erythropoietin. As renal function declines, the incidence of anemia associated with chronic kidney disease increases. It is estimated that 10.9 million patients in Japan have stage 3–5 chronic kidney disease (CKD), of whom 32% suffer from anemia. Globally, CKD is estimated to affect 1 in 10 people and caused more than 1 million deaths in 2017. Anemia is prevalent among patients with CKD because the kidneys no longer produce adequate amounts of erythropoietin, a hormone involved in promoting red blood cell production.

About Daprodustat

Daprodustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI). HIF-PHIs are a novel class of drugs that trigger the body’s adaptation to hypoxia, promote the production of more red blood cells in the bone marrow, thereby reducing anemia and benefiting patients. Daprodustat was developed to provide a convenient oral treatment option, avoiding the administration challenges and refrigeration requirements associated with injectable ESAs/recombinant human erythropoietin. Daprodustat has not yet been approved outside of Japan for the treatment of anemia caused by chronic kidney disease (CKD) or any other indications. Ongoing Phase 3 global clinical programs, including two cardiovascular outcomes studies, ASCEND-D and ASCEND-ND, will support additional regulatory submissions worldwide. In Japan, Duvroq will be exclusively distributed by Kyowa Kirin Co., Ltd. (KKC). KKC possesses strong expertise and experience in the treatment of anemia associated with CKD, ensuring that this innovative medication is accessible to patients.

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