The most common side effects include
high blood pressure, thrombotic vascular events, abdominal pain, dizziness, and allergic reactions.[3][4]
Daprodustat was approved for medical use in Japan in June 2020,[5][6] and in the United States in February 2023.[2][3][7][8] making it the first oral treatment for anemia caused by chronic kidney disease for adults in the US.[3] The US
Food and Drug Administration (FDA) considers it to be a
first-in-class medication.[9]
Medical uses
Daprodustat is
indicated for the treatment of anemia due to chronic kidney disease.[2]
The FDA label for daprodustat has a
boxed warning for an increased risk of thrombotic vascular (blood clotting) events including death, heart attack, stroke, and blood clots in the lung, legs, or dialysis access site.[4]
The most common side effects include high blood pressure, thrombotic vascular events, abdominal pain, dizziness, and allergic reactions.[3][4]
History
The efficacy and safety of daprodustat were evaluated in 2,964 adults with anemia due to chronic kidney disease on dialysis and receiving an erythropoiesis-stimulating agent at the time of study entry in a randomized, sponsor-blind, active-controlled, global, multicenter, event-driven clinical trial (ASCEND-D; NCT02879305).[4][10] Participants were stratified by dialysis type and were required to be on dialysis for at least four months prior to the first dose of daprodustat.[4] Participants on hemodialysis were randomized 1:1 to receive oral daprodustat (N=1,316) or intravenous
epoetin alfa (N=1,308) while participants on
peritoneal dialysis were randomized 1:1 to receive oral daprodustat (N=171) or subcutaneous
darbepoetin alfa (N=169).[4] In this study, adults received either oral daprodustat or injected
recombinant human erythropoietin (rhEPO) (a standard of care treatment for people with anemia due to chronic kidney disease).[3][4] Daprodustat raised and maintained the hemoglobin (the protein in red blood cells that carries oxygen and is a common measure of anemia) within the target range of 10 to 11 g/dL, similar to that of the rhEPO treatment.[3][4] The trial was conducted at 431 sites in 35 countries.[4]
The FDA granted the approval of Jesduvroq to GlaxoSmithKline LLC.[3]
^Clinical trial number NCT02879305 for "Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Dialysis (ASCEND-D)" at
ClinicalTrials.gov
^Thevis M, Milosovich S, Licea-Perez H, Knecht D, Cavalier T, Schänzer W (August 2016). "Mass spectrometric characterization of a prolyl hydroxylase inhibitor GSK1278863, its bishydroxylated metabolite, and its implementation into routine doping controls". Drug Testing and Analysis. 8 (8): 858–63.
doi:
10.1002/dta.1870.
PMID26361079.