FDA accept New Drug Application for GSK’s daprodustat

GSK has announced the FDA has accepted the New Drug Application (NDA) for daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for the potential treatment of patients with anaemia of chronic kidney disease (CKD).

The regulatory submission for the treatment of anaemia of CKD is based on the Phase II clinical trial programme, ASCEND, consisting of five trials. All of these trials met their primary efficacy and safety endpoints in no-dialysis and dialysis patients.

Daprodustat was developed based upon the unique Nobel Prize-winning science that demonstrated how cells sense and adapt to oxygen availability. The FDA regulatory submission acceptance is the third major regulatory milestone for daprodustat following the EMA regulatory submission acceptance, and approval of Duvroq in Japan.

The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of 1 February 2023. The act was created in 1992, and authorises the FDA to collect fees from companies that produce certain human drug and biological products.

The ASCEND programme includes five Phase III trials to assess the efficacy and safety profile of daprodustat for treating anaemia of CKD across the disease pathway. The programme enrolled over 8,000 patients treated for up to 4.26 years.

Results from all five trials were presented at the America Society of Nephrology’s Kidney Week 2021.

CKD, characterised by progressive loss of kidney function, is an increasing global public health burden, in which anaemia is an important and frequent complication of CKD. It is often poorly diagnosed, and undertreated, in patients with early-stage CKD – such as those not on dialysis.

Risk factors for CKD include hypertension, diabetes, obesity, and primary renal disorders. CKD is also an independent risk factor for cardiovascular disease.

Over 700 million suffer worldwide from CKD, and among this number, an estimated 1 in 7 have anaemia. Left untreated or undertreated, anaemia of CKD is associated with poor clinical outcomes, and leads to a substantial burden on patients and healthcare systems.

Ana Ovey