GlaxoSmithKline: FDA Accepts Daprodustat NDA For Review - Quick Facts

(RTTNews) - GlaxoSmithKline plc (GSK, GSK.L) announced the FDA accepted the New Drug Application for daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, for the potential treatment of patients with anaemia of chronic kidney disease. The FDA has assigned a PDUFA action date of 1 February 2023. The daprodustat NDA is based on positive results from the ASCEND phase III clinical trial programme.

Daprodustat is approved in Japan as Duvroq for patients with renal anaemia. In March 2022, the European Medicines Agency validated the marketing authorisation application for daprodustat, which is under review.