Update on US regulatory review of roxadustat in anaemia of chronic kidney disease
18 December 2020 22:00 GMT Update on US regulatory review of roxadustat in anaemia of chronic kidney disease The US Food and Drug Administration (FDA) has requested further clarifying analyses of clinical data, to complete its review of the New Drug Application (NDA) for roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor for patients with anaemia of chronic kidney disease (CKD). AstraZeneca and FibroGen, Inc. (FibroGen) are committed to working with the FDA and have agreed to submit the additional clarifying analyses as soon as possible to