GSK Says FDA Approved Daprodustat To Treat Anaemia Due To CKD

GSK plc (GSK.L) Thursday said the US Food and Drug Administration (FDA) has approved daprodustat (Jesduvroq) for the treatment of anaemia due to chronic kidney disease (CKD) in adults.

The FDA approval is based on the results from SCEND-D trial, assessing the efficacy and safety of daprodustat for the treatment of anaemia of CKD in patients on dialysis, the company said.

A marketing authorisation application for daprodustat is currently under review with the European Medicines Agency, with a regulatory decision expected in the first half of this year. In June 2020, the drug was approved in Japan to treat patients with anaemia of CKD.

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