The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of February 1, 2023, for daprodustat.
The FDA has accepted GlaxoSmithKline’s new drug application (NDA) for daprodustat for the treatment of patients with anemia of chronic kidney disease (CKD). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of February 1, 2023.
The application is based on results from two phase 3 trials—ASCEND-ND and ASCEND-D. These trials showed that daprodustat improved and/or maintained hemoglobin within the target level without increased major adverse cardiovascular events (MACE) in the intention-to-treat populations when compared with the standard of care, an erythropoietin stimulating agent, across both non-dialysis and dialysis patient settings.
The ASCEND program includes five phase 3 trials to assess the efficacy and safety profile of daprodustat for treating anemia of CKD across the disease pathway. The program enrolled more than 8,000 patients treated for up to 4.26 years.
Daprodustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI).
Daprodustat is currently approved in Japan as Duvroq for patients with renal anaemia. In March 2022, the European Medicines Agency validated the marketing authorization application (MAA) for daprodustat, which is currently under review. GlaxoSmithKline anticipates additional regulatory filings to continue throughout 2022.
CKD is characterized by progressive loss of kidney function and is a risk factor for cardiovascular disease. Anemia is a frequent complication of CKD, but it is often poorly diagnosed and undertreated in patients with early-stage CKD, such as those not on dialysis. More than 700 million patients suffer from CKD worldwide, and an estimated one in seven of these patients have anemia.