The British drugmaker’s regulatory submission was based on the Phase 3 ASCEND clinical trial programme, where all the five studies met their primary efficacy and safety endpoints
GSK’s daprodustat will treat anaemia of CKD. (Credit: Robina Weermeijer on Unsplash)
GlaxoSmithKline (GSK) announced that the US Food and Drug Administration (FDA) accepted its New Drug Application (NDA) for daprodustat to treat a type of anaemia.
Daprodustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI). The NDA indicates the drug for patients with anaemia of chronic kidney disease (CKD).
The drug works by the inhibition of oxygen-sensing prolyl hydroxylase enzymes to stabilise the hypoxia-inducible factors, leading to the correction of anaemia.
The US health agency has allotted a Prescription Drug User Fee Act (PDUFA) action date of 1 February 2023 for daprodustat.
GSK said that its HIF-PHI drug was developed using a unique Nobel Prize-winning science that confirmed how cells sense and adapt to oxygen availability.
Daprodustat is currently approved in Japan as Duvroq to treat patients with renal anaemia.
Last month, the European Medicines Agency (EMA) validated the marketing authorisation application (MAA) for daprodustat, which is currently under review.
The British drugmaker’s NDA for daprodustat is based on positive results from the Phase 3 ASCEND programme, containing five clinical trials.
The five clinical studies are designed to evaluate the efficacy and safety of daprodustat in treating anaemia of CKD across the disease pathway.
The programme enrolled more than 8,000 non-dialysis and dialysis CKD patients, to receive treatment using daprodustat or standard of care, for up to 4.26 years.
The ASCEND-ND study enrolled 3,872 non-dialysis dependent patients with anaemia of CKD, while ASCEND-D study enrolled 2,964 dialysis patients and both have met their primary efficacy and safety endpoints.
In the ASCEND trials, GSK’s HIF-PHI drug showed improvement and maintained haemoglobin (Hb) within the target level, across non-dialysis and dialysis patients.
Also, the drug has prevented major adverse cardiovascular events (MACE), compared to the standard of care, erythropoietin stimulating agent (ESA).
CKD is a chronic disease where kidneys gradually lose their function and are often associated with hypertension, diabetes, obesity and primary renal disorders as risk factors.