The US FDA approval of Jesduvroq is based on results from the ASCEND-D trial, which evaluated the efficacy and safety of the drug in treating anaemia of CKD in dialysis patients
GSK House, London, UK. (Credit: GSK plc)
British drugmaker GSK has received the US Food and Drug Administration (FDA) approval for Jesduvroq (daprodustat) to treat anaemia caused by chronic kidney disease (CKD).
Jesduvroq is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), which works by inhibiting the oxygen-sensing prolyl hydroxylase enzymes to stabilise hypoxia-inducible factors that will help in the correction of anaemia.
The drug is indicated as a once-daily treatment of anaemia due to CKD in adults who are on dialysis for at least four months and is not approved for patients who are not on dialysis.
It is the first treatment for anaemia in more than three decades and is the only HIF-PHI approved in the US to provide a new oral treatment option in this indication, the British firm said.
GSK president and chief scientific officer Tony Wood said: “Over the last several decades, there has been little innovation in anaemia of CKD. We are proud to have developed Jesduvroq as a new oral treatment where there is a patient desire for more options.”
The US FDA approved Jesduvroq based on results from the ASCEND-D trial, which evaluated the efficacy and safety of the drug in treating the anaemia of CKD in dialysis patients.
Jesduvroq comes with a boxed warning for increased risk of death, myocardial infarction, stroke, venous thromboembolism, and thrombosis of vascular access.
The drug increases the risk of thrombotic vascular events, including major adverse cardiovascular events (MACE), said the British drugmaker.
GSK’s marketing authorisation application for daprodustat is currently under review by the European Medicines Agency, and a regulatory decision is expected in the first half of 2023.
In June 2020, Japan’s Ministry of Health, Labour and Welfare (MHLW) approved daprodustat, under the brand name Duvroq, to treat patients with anaemia of CKD.
In a separate development, GSK has secured the US Food and Drug Administration (FDA) Orphan Drug Designation (ODD) for Benlysta (belimumab) to treat systemic sclerosis.
Benlysta is a fully human monoclonal antibody that specifically inhibits the B-lymphocyte stimulator (BLyS), which is found in patients with systemic autoimmune diseases.
GSK intends to conduct a Phase 2/3 clinical trial of belimumab for systemic sclerosis-associated interstitial lung disease (SSc-ILD) in the first half of 2023.