The application is based on positive results from the ASCEND phase 3 clinical trial, assessing the efficacy and safety of daprodustat for the treatment of anemia from chronic kidney disease.
The FDA has accepted a new drug application for daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibiter, for the potential treatment of individuals with anemia of chronic kidney disease (CKD), GlaxoSmithKline said in a statement.
Daprodustat demonstrates how cells sense and adapt to oxygen availability. The oral medication can lead to the transcription of erythrolein and other genes involved in the correction of anemia, similar to the physiological effects that occur in the body at high altitudes. It is intended for both individuals on and not on dialysis.
The FDA has assigned a Prescription Drug User Fee Act action date of February 1, 2023.
The application is based on positive results from the ASCEND phase 3 clinical trial, which included 5 pivotal trials assessing the efficacy and safety of the drug for the treatment of anemia across the spectrum of CKD.
The program enrolled more than 8000 individuals who were treated for up to 4.26 years.
Findings from the ASCEND-ND and ASCEND-D were published in the New England Journal of Medicine and investigated individuals not on dialysis and on dialysis.
In the ASCEND-ND trial, investigators enrolled 3872 individuals who were not dialysis-dependent and had anemia from CKD. The individuals received daprodustat or the standard of care, darbepoetin alfa, as a control. The iron management protocols were instituted across both arms of the trial.
The trial med the primary efficacy and safety endpoints and showed that daprodustat improved and/or maintained hemoglobin (Hb) within the target levels for the individuals.
The primary safety analysis showed that daprodustat achieved non-inferiority of major adverse cardiovascular events (MACE) compared to the standard of care in the intention to treat population.
Likewise, in the ASCEND study, investigators included 2964 individuals who were on dialysis and had anemia from CKD. An iron management protocol was used across both arms of a trial.
The trial met its primary efficacy and safety endpoints similarly to ASCEND-ND. The trial also showed that daprodustat improved or maintained Hb within target levels for individuals and achieved non-inferiority of MACE compared to the standard of care used as a control.
Results from all 5 trials were presented at the American Society of Nephrology’s Kidney Week 2021.
Daprodustat is currently approved in Japan for individuals with renal anemia. In March 2022, the European Medicines Agency validated the marketing authorization application for daprodustat and it is currently under review.
Additional regulatory filings are expected to continue throughout 2022.
CKD is characterized by progressive loss of kidney function. The risk factors for CKD include hypertension, diabetes, obesity, and primary renal disorders. Additionally, it is an independent risk factor for cardiovascular disease.
Anemia is a frequent complication of CKD but is often poorly diagnosed and under treated in individuals with early-stage CKD, specifically those not on dialysis. When left untreated or undertreated, it is associated with poor clinical outcomes for individuals.
US Food and Drug Administration accepts new drug application for daprodustat. GSK. News release. April 19, 2022. Accessed April 20, 2022. https://www.gsk.com/en-gb/media/press-releases/us-food-and-drug-administration-accepts-new-drug-application-for-daprodustat/