19 April 2022
FDA accepted a new drug application for daprodustat
GSK announced that the United States Food and Drug Administration (FDA) accepted the new drug application for daprodustat, a treatment for anemia associated with chronic kidney disease.
The regulatory submission was based on the ASCEND phase III clinical trial program, consisting of five trials. Daprodustat met the primary endpoint across all five clinical trials. Treatment with daprodustat resulted in improved or maintained Hb (10-11.5 g/dL) in all the trials.
Daprodustat was previously approved in Japan; regulatory submission was approved in Europe.