FDA Accepts Daprodustat NDA for Anemia of Chronic Kidney Disease
The NDA for daprodustat, a novel investigational agent, is based on data from pivotal ASCEND program clinical trials.
The US Food and Drug Administration (FDA) on April 19, 2022, accepted a New Drug Application (NDA) for daprodustat for the treatment of patients with anemia of chronic kidney disease (CKD), according to a statement from manufacturer GlaxoSmithKline.
The NDA for daprodustat, a hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor, is supported by data from 5 clinical trials comprising the ASCEND phase III program, all of which studies met primary safety and efficacy endpoints in patients across the spectrum of CKD severity, GSK states.
Two key cardiovascular outcomes trials, ASCEND-ND and ASCEND-D evaluated the efficacy and safety of daprodustat in more than 6800 patients with anemia of CKD who were not on dialysis or on dialysis, respectively.
In ASCEND-ND, 3872 non-dialysis dependent patients with anemia of CKD who were either switched from the standard of care, erythropoietin stimulating agent (ESA), or not currently receiving ESA therapy to receive daprodustat or ESA control (darbepoetin alfa).
In ASCEND-D, 2964 dialysis-dependent patients with anemia of CKD were switched to receive daprodustat or ESA control from a standard of care ESA therapy.
A uniform iron management protocol was instituted across both arms in each trial.
Both trials demonstrated that daprodustat improved and/or maintained hemoglobin within the target level (10-11.5 g/dL) without increased major adverse cardiovascular events (non-inferiority of MACE) in the intention-to-treat populations, when compared to the standard of care, ESA, across non-dialysis and dialysis patient settings.
Anemia of CKD is a frequent though often undiagnosed and undertreated complication of CKD and when undetected or poorly managed is associated with poor clinical outcomes. Estimates are that 1 in 7 among the more than 700 million patients with CKD have related anemia, according to the GSK statement.
Daprodustat is now under review by the European Medicine's Agency which accepted GSK's marketing application in March. The HIF-PH inhibitor is approved in Japan where it is marketed as Duvroq.
GSK reports that the FDA has assigned Prescription Drug User Fee Act action date of February 1, 2023.
