GSK One Step Closer To FDA Approval For Anemia Drug For Dialysis Patients

GSK One Step Closer To FDA Approval For Anemia Drug For Dialysis Patients
  • The FDA's Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted 13 to 3 votes in favor of GSK plc's GSK daprodustat for adult dialysis patients with anemia of chronic kidney disease (CKD).
  • In adult non-dialysis patients with anemia of CKD, the CRDAC did not support that the benefit of treatment with daprodustat outweighs the risks with a 5 to 11 vote.
  • In April 2022, the FDA accepted the daprodustat marketing application and assigned a Prescription Drug User Fee Act date of 1 February 2023.
  • CKD affects 700 million patients worldwide, with an estimated one in seven also developing anemia.
  • Daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), was studied in the ASCEND phase 3 trial program, which included five pivotal trials. 
  • All five pivotal trials met the primary endpoints. 
  • In March 2022, the European Medicines Agency validated the marketing authorization application for daprodustat, which is currently under regulatory review, with a regulatory decision anticipated in the first half of 2023. 
  • In June 2020, Japan approved Duvroq (daprodustat) for patients with anemia of CKD. 
  • Price Action: GSK shares are up 0.31% at $32.79 during the premarket session on the last check Thursday.

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