GlaxoSmithKline (GSK) has received the Japanese regulatory approval for its Duvroq (daprodustat) tablets to treat anaemia due to chronic kidney disease (CKD).
Japan’s Ministry of Health, Labour and Welfare has approved the company’s Japanese New Drug Application (JNDA) for Duvroq, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI).
The drug works by inhibiting of oxygen-sensing prolyl hydroxylase enzymes to stabilise hypoxia-inducible factors, and leads to transcription of erythropoietin and other genes associated with the production of RBC and iron metabolism.
GSK said that the drug has been designed to provide an orally-convenient treatment option, avoid administration challenges and need for cold storage of injectable recombinant human erythropoietin.
GSK chief scientific officer and R&D president Hal Barron said: “The approval of Duvroq brings a new, convenient oral treatment option to nearly 3.5 million patients in Japan who have anaemia associated with renal disease.
“We are pleased with this first approval and look forward to sharing data from our ongoing phase III programme as we seek to help many more patients suffering with this disease around the world.”
Regulatory filing for Duvroq is based on positive data from the Phase 3 clinical trials in Japan
Anaemia is commonly found in patients with CKD, as kidneys fail to produce adequate amounts of erythropoietin, a hormone involved in prompting the production of red blood cells.
GSK has filed the JNDA, based on positive data from the Phase 3 clinical programme, conducted in Japan to evaluate Duvroq for anaemia in patients with CKD at different stages.
The Japan clinical studies enrolled patients on dialysis, including both hemo- and peritoneal dialysis, and those not on dialysis, irrespective of prior anaemia treatment with erythropoiesis-stimulating agents (ESAs).
Unlike current standard of care in patients with CKD, which requires injections, Duvroq is said to offer convenience with oral administration and flexibility with once-daily dosing.
GSK said that its Duvroq has not been approved as a treatment for any indication anywhere else in the world, except for anaemia due to CKD in Japan. Kyowa Kirin (KKC) will exclusively distribute Duvroq in Japan, under the proposed commercialisation agreement with the company in 2018.
