Jesduvroq (Daprodustat) Approved by US FDA for Anaemia of Chronic Kidney Disease
Thursday, February 02, 2023
GSK today announced that the US Food and Drug Administration (FDA) has approved Jesduvroq (daprodustat), an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for the once-a-day treatment of anaemia due to chronic kidney disease (CKD) in adults who have receiving dialysis for at least four months.
Jesduvroq is the only oral HIF-PHI approved in the US, offering adults on dialysis with anaemia of chronic kidney disease a new oral treatment option.
The FDA approval is based on results from the ASCEND-D trial, assessing the efficacy and safety of Jesduvroq for the treatment of anaemia of CKD in patients on dialysis.
Jesduvroq, a HIF-PHI, belongs to a novel class of oral medicines for the treatment of anaemia of CKD in adult patients on dialysis. Inhibition of oxygen-sensing prolyl hydroxylase enzymes stabilises hypoxia-inducible factors, leads to transcription of erythropoietin and other genes involved in the correction of anaemia, similar to the physiological effects that occur in the human body at high altitude. Jesduvroq provides an oral treatment option for adult patients with anaemia of CKD on dialysis. Jesduvroq is a tablet available in 5 dosage strengths: 1mg, 2mg, 4mg, 6mg, 8mg.
