Regulatory submission for GSK’s daprodustat accepted in Health Canada review
MISSISSAUGA, ON, July 6, 2022 /CNW/ – GSK announces that Health Canada has agreed to review the New Drug Submission (NDS) for daprodustat, an oral hypoxia-inducible prolyl hydroxylase factor (HIF-PHI) inhibitor, for the potential treatment of patients with anemia related to chronic kidney disease (CKD). Daprodustat was developed based on unique Nobel Prize-winning science that demonstrated how cells sense and adapt to the availability of oxygen.
The NDA for daprodustat is based on the ASCEND Phase III clinical trial program, which included five pivotal trials evaluating the efficacy and safety of daprodustat for the treatment of anemia in a wide range of patients with CKD . The program has enrolled more than 8,000 patients treated for up to 4.26 years. This includes key trials of cardiovascular outcomes 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 kidney anemia and is currently under review by the European Medicines Agency and the US Food and Drug Administration. Additional regulatory filings are expected to continue throughout 2022. Daprodustat is an investigational product that is not currently authorized for sale in Canada.
About Chronic Kidney Disease Anemia CKD is characterized by a progressive loss of kidney function.[iii] Anemia, a deficiency of healthy red blood cells, which are essential for carrying oxygen to all parts of the body, is a significant and common complication of CRF.[iv] However, it is often misdiagnosed and undertreated in patients with CKD, such as those not on dialysis.[iv] More than 700 million patients suffer from CKD worldwide, and it is estimated that one in seven patients suffer from anemia.[v],[vi] When left untreated or undertreated, CKD anemia is associated with poor clinical outcomes and places a significant burden on patients and healthcare systems.[iv]
About daprodustat Daprodustat belongs to a new class of oral medications called hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHI) being investigated as a potential treatment for CKD anemia in adult patients not dialysis and dialysis. Inhibition of oxygen-sensing prolyl hydroxylase enzymes stabilizes hypoxia-inducible factors, which may 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 altitudes.
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References [i] Singh A, et al. Daprodustat for the treatment of anemia in patients not on dialysis. N Engl J Med. 2021;385:2313-2324. [ii] Singh A, et al. Daprodustat for the treatment of anemia in patients on dialysis. NOT English J Med. 2021;385:2325-2335. [iii] Hill NR, Fatoba ST, Oke JL, et al. Worldwide 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 regimens, and health care resource utilization among Medicare and nondialysis-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 United States. PLoS One. 2014;9(1):e84943.
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