However, the CRDAC panel did not support and voted 11-5 against the drug to be used in patients, not on dialysis
GSK gets the backing of US FDA’s CRDAC for use of daprodustat in adult dialysis patients with anaemia of CKD. (Credit: GSK plc.)
GSK said that the US Food and Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) supported the approval of daprodustat for adult dialysis patients with anaemia of chronic kidney disease (CKD), citing that the benefit of the drug outweighs its risks.
The committee voted 13-3 in favour of the oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) for patients on dialysis. However, the panel did not support and voted 11-5 against the drug for patients, not on dialysis.
The FDA accepted the new drug application (NDA) of daprodustat in April 2022 and gave it a Prescription Drug User Fee Act date of 1 February 2023.
The regulator will take into account the vote, feedback, and recommendations from the CRDAC when it reviews the NDA. However, it is not bound by the panel’s recommendation.
GSK development senior vice president Chris Corsico said: “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.
“We want to thank the physicians, patients and advocacy community who shared their valuable insights about this disease. We look forward to continuing to work with the US FDA as they complete their review of our new drug application.”
In the ASCEND phase 3 clinical trial programme, daprodustat met all the primary endpoints in all its five pivotal phase 3 trials.
The late-stage clinical trial programme enrolled over 8,000 patients, who were treated for up to 4.26 years. All five pivotal trials tested the efficacy and safety of daprodustat for the treatment of anaemia throughout the spectrum of CKD.
In June 2020, daprodustat with the brand name Duvroq was approved in Japan in June 2020 for the treatment of patients having anaemia of CKD.