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HomeLatest Pharma-NewsFibroGen Submits New Drug Application to the U.S. FDA for Roxadustat for...

FibroGen Submits New Drug Application to the U.S. FDA for Roxadustat for the treatment of anemia of chronic kidney disease (CKD)

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.

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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

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