The US Food and Drug Administration (FDA) has given the green light to Jesduvroq, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) for the treatment of adults with chronic kidney disease (CKD) and anaemia who are on dialysis for at least four months.
Developed by GSK PLC (LSE:GSK, NYSE:GSK), Jesduvroq is the first innovative medicine for anaemia treatment in over 30 years and the only HIF-PHI approved in the US.
Chief scientific officer Tony Wood said: "We are proud to have developed Jesduvroq as a new oral treatment where there is a patient desire for more options."
The approval was based on results from the ASCEND-D trial, which evaluated the efficacy and safety of Jesduvroq. The trial results were published in the New England Journal of Medicine.