Posted by Michael Wonder on 24 Dec 2019
FibroGen submits new drug application to the U.S. FDA for roxadustat in patients with anaemia of chronic kidney disease
23 December 2019 - New drug application supported by positive global Phase 3 efficacy and safety results.
FibroGen today announced the submission of a new drug application to the U.S. FDA for roxadustat for the treatment of anaemia of chronic kidney disease (CKD), in both non-dialysis-dependent and dialysis-dependent CKD patients.
Roxadustat is the first orally administered small molecule hypoxia-inducible factor prolyl hydroxylase inhibitor submitted for FDA regulatory approval for the treatment of anaemia 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.
