FibroGen files NDA to FDA for roxadustat for the treatment of anemia of chronic kidney disease.
FibroGen, Inc.announced the submission of a New Drug Application (NDA) to the 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 III program encompassing 15 trials that enrolled more than 10,000 patients, worldwide.
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