- Jesduvroq is the only oral HIF-PHI approved in the US, offering adults on dialysis with anaemia of chronic kidney disease a new oral treatment option
The FDA approval is based on results from the ASCEND-D trial, assessing the efficacy and safety of Jesduvroq for the treatment of anaemia of CKD in patients on dialysis. Results were published in the
The Safety Information for Jesduvroq includes a boxed warning for increased risk of death, myocardial infarction, stroke, venous thromboembolism, and thrombosis of vascular access. Jesduvroq increases the risk of thrombotic vascular events, including major adverse cardiovascular events (MACE). Targeting a hemoglobin level greater than 11 g/dL is expected to further increase the risk of death and arterial venous thrombotic events, as occurs with erythropoietin stimulating agents (ESAs), which also increase erythropoietin levels. No trial has identified a hemoglobin target level, dose of Jesduvroq, or dosing strategy that does not increase these risks. Use the lowest dose of Jesduvroq sufficient to reduce the need for red blood cell transfusions. Jesduvroq has not been shown to improve quality of life, fatigue, or patient well-being. Jesduvroq is not indicated for use as a substitute for red blood cell transfusions in patients who require immediate correction of anaemia or for treatment of anaemia of chronic kidney disease in patients who are not on dialysis.
CKD is an increasing global health burden affecting 700 million patients worldwide, with an estimated one in seven patients also developing anaemia.1,2 When left untreated or undertreated, anaemia of CKD is associated with poor clinical outcomes and leads to a substantial burden on patients and healthcare systems.3 There is an unmet need for oral treatment options with efficacy and safety comparable to current treatments.
A marketing authorisation application for daprodustat is currently under review with the
About Jesduvroq (daprodustat)
Jesduvroq, a HIF-PHI, belongs to a novel class of oral medicines for the treatment of anaemia of CKD in adult patients on dialysis. Inhibition of oxygen-sensing prolyl hydroxylase enzymes stabilises hypoxia-inducible factors, which can lead to transcription of erythropoietin and other genes involved in the correction of anaemia, similar to the physiological effects that occur in the human body at high altitude.4,5 Jesduvroq provides an oral treatment option for adult patients with anaemia of CKD on dialysis.6 Jesduvroq is a tablet available in 5 dosage strengths: 1mg, 2mg, 4mg, 6mg, 8mg.
About the ASCEND Phase III clinical trial programme
The ASCEND programme included five Phase III trials to assess the efficacy and safety profile of daprodustat for the treatment of anaemia of CKD across the disease spectrum. The programme enrolled over 8,000 patients who were treated for up to 4.26 years. Results from all five trials were presented at the
Results from the pivotal cardiovascular outcomes trial, ASCEND-D, which investigated patients on dialysis, were published in the
- ASCEND-D (Anaemia Studies in CKD: Erythropoiesis via a Novel PHI Daprodustat-Dialysis) enrolled 2,964 dialysis patients with anaemia of CKD who were switched to receive daprodustat
About anaemia of chronic kidney disease
CKD is characterised by progressive loss of kidney function.7 Anemia is an important and frequent complication of CKD and is associated with increased morbidity, mortality and reduced quality of life.8 It is often poorly diagnosed and undertreated in patients with early-stage CKD.9 Over 700 million patients suffer from CKD worldwide, and an estimated 1-in-7 of these patients have anaemia.1,2 CKD affects approximately 39 million people in the US, of whom approximately 6 million are also affected by anaemia.1,2 There are approximately 810,000 patients who are end-stage renal disease (ESRD) in the US.10 Of which, there are 558,000 patients receiving dialysis.10 Of these patients receiving dialysis, 481,000 received hemodialysis and 77,000 received home or peritoneal dialysis.10 When left untreated or undertreated, anaemia of CKD is associated with poor clinical outcomes and leads to a substantial burden on patients and healthcare systems.3
Please consult the full Prescribing Information including Boxed Warning and Medication Guide.
About GSK
GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com/company
References
[1] 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.
[2] Stauffer et al. Prevalence of anemia in chronic kidney disease in
[3] Hanna RM et al. Burden of anemia in chronic kidney disease: beyond erythropoietin.
[4] Ariazi JL, Duffy KJ, Adams DF, et al. Discovery and preclinical characterization of GSK1278863 (daprodustat), a small molecule hypoxia inducible factor-prolyl hydroxylase inhibitor for anemia. J Pharmacol Exp Ther. 2017;363(3):336-347.
[5] Maxwell PH, Eckardt KU. HIF prolyl hydroxylase inhibitors for the treatment of renal anaemia and beyond. Nat Rev Nephrol. 2016;12(3):157-168.
[6] Singh A, et al. Daprodustat for the Treatment of Anemia in Patients Undergoing Dialysis. N Engl J Med. 2021;385:2325-2335.
[7] 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.
[8] Palaka E, et al. The Impact of CKD Anaemia on Patients: Incidence, Risk Factors, and Clinical Outcomes-A Systematic Literature Review. Int J Nephrol. 2020
[9]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
[10] United States Renal Data System. 2022 USRDS Annual Data Report: Epidemiology of kidney disease in
.
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