Regulatory submission for GSK’s daprodustat accepted into Health Canada review

  • Canadian regulatory submission acceptance follows that of the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) as well as the approval of Duvroq in Japan.

Mississauga, Ontario - GSK announces that Health Canada has accepted into review the New Drug Submission (NDS) for daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for the potential treatment of patients with anemia of chronic kidney disease (CKD). Daprodustat was developed based upon the unique Nobel Prize-winning science that demonstrated how cells sense and adapt to oxygen availability.

The daprodustat NDS is based on the ASCEND phase III clinical trial program, which included five pivotal trials assessing the efficacy and safety of daprodustat for the treatment of anemia across a broad spectrum of CKD patients. The program enrolled over 8,000 patients treated for up to 4.26 years. This includes key cardiovascular outcomes trials in non-dialysis (ASCEND-ND) and dialysis (ASCEND-D) CKD patients that were published in the New England Journal of Medicine in November 2021.[i],[ii]

Daprodustat is approved in Japan as Duvroq for patients with renal anemia and is currently under review by the European Medicines Agency and the US Food and Drug Administration. Additional regulatory filings are anticipated to continue throughout 2022. Daprodustat is an investigational product that is not currently authorized for sale in Canada.

About anemia of chronic kidney disease

CKD is characterized by progressive loss of kidney function.[iii] Anemia, a deficiency of healthy red blood cells, which are essential to carry oxygen to all parts of the body, is an important and frequent complication of CKD.[iv] However, it is often poorly diagnosed and undertreated in patients with CKD, such as those not on dialysis.[iv] Over 700 million patients suffer from CKD worldwide, and an estimated 1-in-7 of these patients have anemia.[v],[vi] When left untreated or undertreated, anemia of CKD is associated with poor clinical outcomes and leads to a substantial burden on patients and healthcare systems.[iv]

About daprodustat

Daprodustat belongs to a novel class of oral medicines called the hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHI) being investigated as a potential treatment of anemia of CKD in non-dialysis and dialysis adult patients. Inhibition of oxygen-sensing prolyl hydroxylase enzymes stabilizes hypoxia-inducible factors, which can lead to transcription of erythropoietin and other genes involved in the correction of anemia, similar to the physiological effects that occur in the human body at high altitude.

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[i] Singh A, et al. Daprodustat for the Treatment of Anemia in Patients Not Undergoing Dialysis. N Engl J Med. 2021;385:2313-2324.

[ii] Singh A, et al. Daprodustat for the Treatment of Anemia in Patients Undergoing Dialysis. N Engl J Med. 2021;385:2325-2335. 

[iii]  Hill NR, Fatoba ST, Oke JL, et al. Global prevalence of chronic kidney disease - A systematic review and meta-analysis. PLoS One. 2016;11(7):e0158765.

[iv] St Peter WL, Guo H, Kabadi S, et al. Prevalence, treatment patterns, and healthcare resource utilization in Medicare and commercially insured non-dialysis-dependent chronic kidney disease patients with and without anemia in the United States. BMC Nephrol. 2018;19(1):67.

[v] Bikbov B, Purcell CA, Levey AS, et al. Global, regional, and national burden of chronic kidney disease, 1990–2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2020;395(10225):709-733..

[vi] Stauffer ME, Fan T. Prevalence of anemia in chronic kidney disease in the United States. PLoS One. 2014;9(1):e84943.