Dec. 23, 2019: FibroGen announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for roxadustat for the treatment of anemia of chronic kidney disease (CKD), in both non-dialysis-dependent (NDD) and dialysis-dependent (DD) CKD patients.
Roxadustat (FG-4592) is the first orally administered small molecule hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor that is submitted to FDA regulatory approval for the treatment of anemia of CKD.
Regulatory approval of roxadustat is supported by the positive results from a global Phase 3 program encompassing 15 trials that enrolled above 10,000 patients, worldwide. https://fda.einnews.com/pr_news/505579171/fibrogen-submits-new-drug-application-to-the-u-s-fda-for-roxadustat-in-patients-with-anemia-of-chronic-kidney-disease
