Data from Pharmawand - Curated by EPG Health - Date added 13 February 2020

FibroGen, Inc. announced that the 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 December 20, 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 III program encompassing more than 8,000 patients.

Roxadustat is currently approved in China for the treatment of anemia in patients with CKD, regardless of whether they require dialysis, and in Japan for the treatment of dialysis patients with anemia of CKD. FibroGen’s partner Astellas also intends to file a marketing authorization application with the European Medicines Agency in the first half of 2020.


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