FibroGen has completed enrolling patients in a Phase lll trial programme that aims to evaluate the use of roxadustat for the treatment of anaemia in both dialysis-dependent and non-dialysis-dependent patients with chronic kidney disease (CKD).
The programme comprises seven studies sponsored by FibroGen and its partners Astellas Pharma and AstraZeneca.
Around 9,000 CKD patients were enrolled in the programme, which expects to include subpopulations of patients initiating dialysis (incident dialysis) and patients with inflammation.
FibroGen chief medical officer K Peony Yu said: “We are pleased to have achieved this critical step in our roxadustat Phase lll clinical programme, and we look forward to reporting topline results from these studies by the end of this year, with pooled safety analyses available in 2019.
“The results of these studies will support the submission of a US new drug application (NDA) in the first half of 2019.”
Results from previously completed Phase ll studies and Phase lll trials of roxadustat in China and Japan have showed the solution to be effective in correcting and/or maintaining haemoglobin levels in various populations of CKD patients with anaemia.
Roxadustat has also demonstrated positive effects on iron metabolism, and its ability to correct and maintain haemoglobin levels without requiring concomitant administration of intravenous iron.
It is an orally administered small molecule currently being developed as a potential therapy for anaemia associated with CKD, which is a serious medical condition where patients have insufficient red blood cells and low levels of haemoglobin (Hb), a protein in red blood cells that carries oxygen to cells throughout the body.
Many of the CKD patients die from cardiovascular events before they begin dialysis.