US FDA accepts GSK application for kidney disease drug

GlaxoSmithKline said the US Food and Drug Administration (FDA) had accepted its application for its chronic kidney disease drug daprodustat.

The application was based on positive results from a phase III clinical trial programme, which assessed the efficacy and safety of daprodustat for the treatment of anaemia across the spectrum of kidney disease, GSK said.

It added that five trials that all met their primary efficacy and safety endpoints in non-dialysis and dialysis patients.

Daprodustat is currently approved in Japan as Duvroq for patients with renal anaemia. In March, the European Medicines Agency validated the marketing authorisation application for the drug, which is currently under review. GSK said additional regulatory filings are anticipated to continue throughout 2022.