Tag: Roxadustat

FDA Advisory Committee: roxadustat does not support approvals in anaemia of chronic kidney disease
July 16, 2021 Off

FDA Advisory Committee: roxadustat does not support approvals in anaemia of chronic kidney disease

By Dino Mustafić

The Food and Drug Administration’s (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) has reached almost unanimous vote that the benefit-risk profile of roxadustat does not support approval for the treatment of anaemia in chronic kidney disease (CKD) in non-dialysis dependent (NDD) adult patients, and that the benefit-risk profile of roxadustat does not support approval for the treatment of anaemia in CKD in dialysis-dependent (DD) adult patients.

November 11, 2019 Off

Roxadustat phase 3 show treatment of anaemia from chronic kidney disease: AstraZeneca, FibroGen

By Dino Mustafić

AstraZeneca and FibroGen’s pooled cardiovascular (CV) safety analyses showed that roxadustat, an oral first-in-class hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), did not increase the risk of MACE, MACE+ and all-cause mortality in non dialysis-dependent (NDD) patients compared to placebo and dialysis-dependent (DD) patients compared to epoetin alfa, a current medicine used to treat anaemia.