FDA Approves First Oral Treatment For Anemia Due To Chronic Kidney Disease

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  • The FDA has approved GSK plc's GSK Jesduvroq (daprodustat) for anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least four months. 
  • Jesduvroq is the first innovative medicine for anemia treatment in over 30 years, and the only hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) approved in the U.S.
  • Related: GSK Looking For Under-Appreciated M&A Targets, Not Trying To Be Next Roche Or AstraZeneca.
  • The FDA approval is based on results from the ASCEND-D trial. Results were published in the New England Journal of Medicine, with additional results published in the New England Journal of Medicine supplementary appendix.
  • A marketing authorization application for daprodustat is currently under review with the European Medicines Agency, with a regulatory decision anticipated in the first half of 2023. 
  • In June 2020, daprodustat tablets were approved by Japan's Ministry of Health, Labour and Welfare for the treatment of patients with anemia of CKD. 
  • Wednesday, GSK reported an adjusted fourth-quarter profit of 25.8 pence per share on sales of about £7.4 billion, up 4.2% Y/Y. Blockbuster shingles treatment brought in £3 billion in sales after 72% growth year on year.
  • Price Action: GSK shares are up 0.11% at $35.53 during the premarket session on the last check Thursday.
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