Posted by Michael Wonder on 12 Feb 2020
FibroGen announces U.S. FDA acceptance of new drug application for roxadustat for the treatment of anaemia of chronic kidney disease
11 February 2020 - FibroGen, Inc. (NASDAQ:FGEN) today announced that the U.S. Food and Drug Administration (FDA) has completed its filing review of its New Drug Application (NDA) for roxadustat for the treatment of anemia of chronic kidney disease (CKD), in both non-dialysis-dependent (NDD) and dialysis-dependent (DD) patients. The application will be considered filed on February 18, 2020.
The FDA has set a Prescription Drug User Fee Act (PDUFA) date of 20 December 2020.
Roxadustat is the first orally administered small molecule hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor accepted by the FDA for review for the treatment of anemia of CKD. The submission is supported by positive results from a global Phase 3 program encompassing more than 8,000 patients.
