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

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.