GSK’s daprodustat for adult dialysis patients with anaemia of chronic kidney disease (CKD) has been supported by the US Food and Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) with a 13 to three vote, the company announced.
The advisory committee experts, however, voted 11 to five against the use of daprodustat in non-dialysis patients with anaemia of CKD, citing increased safety risks such as heart failure and bleeding gastric erosions.
The FDA will consider the vote, feedback and recommendations from the CRDAC as it reviews the New Drug Application for daprodustat, with a final decision expected by 1 February 2023.
CKD, characterised by progressive loss of kidney function, is an increasing global public health burden affecting 700 million patients worldwide, with an estimated one in seven patients also developing anaemia.
Risk factors for CKD include hypertension, diabetes, obesity and primary renal disorders and, 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.
There remains an unmet need for convenient treatment options with efficacy and safety comparable to current treatments, GSK said.
Chris Corsico, senior vice president, development, GSK, commented: “Today’s robust discussion was an important step in the review of daprodustat. We are pleased the committee recognised the potential for daprodustat to help certain patients who are living with anaemia of CKD given limited treatment options.”
Daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), was studied in the ASCEND phase 3 clinical trial programme, which included five pivotal trials assessing the efficacy and safety profile of daprodustat for the treatment of anaemia across the spectrum of CKD.
All five pivotal trials, which together enrolled over 8,000 patients treated for up to 4.26 years, met their primary endpoints. Results from all five trials were presented at the American Society of Nephrology’s Kidney Week 2021.
To date, daprodustat tablets have only been approved by Japan in June 2020 to treat patients with renal anaemia, sold under the brand Duvroq. In March 2022, the European Medicines Agency validated the marketing authorisation application for daprodustat, which is currently under regulatory review, with a regulatory decision anticipated in the first half of 2023.