FibroGen Submits New Drug Application for Anemia of Chronic Kidney Disease

 FibroGen, Inc., (NASDAQ:FGEN), today 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 is the first orally administered small molecule hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor submitted for FDA regulatory approval for the treatment of anemia of CKD. Regulatory approval of roxadustat is supported by positive results from a global Phase 3 program encompassing 15 trials that enrolled more than 10,000 patients, worldwide.

“The submission of this NDA is a major step toward our goal of bringing this novel oral medicine to U.S. patients suffering from anemia in CKD,” said Jim Schoeneck, Interim Chief Executive Officer, FibroGen. “We, in collaboration with our partner AstraZeneca, look forward to working with the FDA during the NDA review, and to the potential of roxadustat as a new therapeutic option for treating CKD anemia, in patients on dialysis and not on dialysis.”

https://www.biospace.com/article/releases/fibrogen-submits-new-drug-application-to-the-u-s-fda-for-roxadustat-in-patients-with-anemia-of-chronic-kidney-diseasenew-drug-application-supported-by-positive-global-phase-3-efficacy-and-safety-results/