The US Food and Drug Administration (FDA) has approved Jesduvroq (daprodustat) for the once-a-day treatment of anaemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least four months.
Jesduvroq is the first oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) approved in the US.
Tony Wood, President and Chief Scientific Officer, GSK, 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 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.
CKD is an increasing global health burden affecting 700 million patients worldwide, with an estimated one in seven patients also developing anaemia. When left untreated or undertreated, anaemia of CKD is associated with poor clinical outcomes and leads to a substantial burden on patients and healthcare systems.
LaVarne Burton, President and Chief Executive Officer, American Kidney Fund, said: “Anaemia of CKD can be a debilitating condition that is challenging to manage. This news means that patients on dialysis who are living with anaemia of CKD now have another treatment option to help manage their anaemia.”
A marketing authorisation application for daprodustat is currently under review with the European Medicines Agency, with a regulatory decision anticipated in the first half of 2023. Daprodustat tablets (under the brand name Duvroq) are already approved in Japan for the treatment of patients with anaemia of CKD.