Duvroq is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, which is yet to be approved for any indication anywhere else in the world with the exception of Japan.
The drug’s Japanese New Drug Application (JNDA) was approved by the Ministry of Health, Labour and Welfare, and was based primarily on positive data from a phase 3 programme, comprising three trials, held in Japan.
The JNDA was submitted by GSK to the Japanese Ministry in August 2019.
The three phase 3 clinical trials that made up the programme assessed the drug for the treatment of anaemia in patients across the spectrum of chronic kidney disease from stages three-five. Included in the trials were patients on dialysis, which in turn including hemo- and peritoneal dialysis, and also those not on dialysis, irrespective of prior anaemia treatment with erythropoiesis-stimulating agents (ESAs).
In comparison to the current standard of care in anaemia patients with chronic kidney disease which requires injections, Duvroq provides convenience with oral administration and flexibility with daily once dosing for dialysis and non-dialysis patients, said GSK.
The pharma major said that daprodustat’s ongoing phase 3 global programme, which comprises two cardiovascular outcome studies ASCEND-D and ASCEND-ND, will support additional regulatory submissions for the drug candidate in other parts of the world.
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.”
GSK said that Duvroq will be distributed exclusively in Japan by Kyowa Kirin based on a commercialisation deal signed in 2018.