FibroGen presents two phase 3 study results of Roxadustat in CKD treatment
FibroGen announced the presentation of results from two Phase 3 multi-center, randomized, controlled clinical trials of roxadustat for the treatment of anemia associated with chronic kidney disease, or CKD, conducted in China at the American Society of Nephrology Kidney Week 2018 annual meeting in San Diego, California. Roxadustat is a first-in-class oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) in late-stage development for the treatment of anemia associated with CKD both in patients on dialysis and in patients not on dialysis. "The results of two Phase 3 trials in dialysis-dependent and non-dialysis-dependent CKD patients in China showed roxadustat effectively corrected and maintained hemoglobin levels, and are the basis of our new drug application currently under review by the National Medical Products Administration. These results are consistent with findings from multiple Phase 3 clinical studies reported to date by FibroGen and our partners, supporting roxadustat as the potential first oral drug for the treatment of anemia associated with chronic kidney disease, a serious and potentially life-threatening condition," said Peony Yu, M.D., Chief Medical Officer of FibroGen. "If approved in China, roxadustat will be the first HIF-PHI available to help CKD patients with anemia, and patients in China could be first to gain access to treatment with roxadustat."