GSK receives first regulatory approval for Duvroq (daprodustat) in Japan for patients with anaemia due to chronic kidney disease

Daprodustat is currently not approved as a treatment for anaemia due to CKD or any other indication anywhere else in the world other than in Japan. The ongoing phase III global programme, which includes two cardiovascular outcome studies ASCEND-D and ASCEND-ND, will support additional regulatory submissions across the world.

Duvroq is one of the medicines in GSK’s growing portfolio of innovative specialty care products. In Japan, Duvroq will be exclusively distributed by Kyowa Kirin Co., Ltd. (KKC), following the strategic commercialisation deal announced in 2018. KKC has strong established expertise and experience in the treatment of anaemia due to CKD to ensure availability of this innovative medicine to patients. Commercial promotional launch activities will be led by KKC. GSK will support scientific engagement through medical science liaisons.  

About the Japan clinical development programme

The three phase III studies in Japan included:

  • A 52-week study of 271 haemodialysis patients using ESAs prior to the study. It compared daprodustat versus darbepoetin alpha.
  • A 52-week study of 299 patients with stage 3-5 CKD not on dialysis, with or without prior use of ESA. It compared daprodustat versus epoetin beta pegol. Additionally, it included a cohort of 56 patients on peritoneal dialysis who were all treated with daprodustat.
  • A 24-week open label study of haemodialysis in 28 patients who were not receiving ESAs at entry to the study and were all treated with daprodustat.

About the global clinical development programme

GSK also has an ongoing global phase III registration programme, including:

  • ASCEND-D (Anaemia Studies in CKD: Erythropoiesis via a Novel PHI Daprodustat-Dialysis) enrolled approximately 3,000 dialysis dependent patients with anaemia associated with CKD switching from an ESA. Recruitment has completed.
  • ASCEND-ND (Anaemia Studies in CKD: Erythropoiesis via a Novel PHI Daprodustat-Non-Dialysis) will enrol approximately 4,500 non-dialysis dependent patients with anaemia associated with CKD and will include patients either switching from or naive to an ESA. Recruitment remains ongoing.

For both studies, the co-primary endpoints are time to first occurrence of major adverse cardiovascular events (MACE) and mean change in haemoglobin between the baseline and efficacy period (mean over weeks 28-52). The studies will assess whether daprodustat is non-inferior to ESAs on these endpoints as the primary analysis. If non-inferiority of the primary analysis is met, superiority will be assessed for the MACE endpoint.

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