Even after a rigorous discussion, the FDAs cardiovascular and renal drugs advisory committee didnt approve Roxadustat for the treatment of anemia due to chronic kidney disease for patients on and not on dialysis. 

The reasons given for the lack ofapproval were cited to be safety concerns. Roxadustat is an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PI) inhibitor for patients with non-dialysis-dependent chronic kidney disease. The panel also did not approve the use of the drug in patients on dialysis. 

It was suggested that the trial results showed an increased portion of non-dialysis dependent patients with dialysis dependent-CKD patients experienced vascular access thrombosis compared with controls. However, the panel members gave positive indications that the HIF-PI inhibitor could be effective in the treatment of anemia in patients on dialysis who have been hyporesistant to other anemia drugs. 

Reference: Neumann ME. FDA panel does not recommend approval of Roxadustat for anemia. Nephrology News and issues. 2021. Accessed on 20th August 2021 from https://www.healio.com/news/nephrology/20210816/fda-panel-does-not-recommend-approval-of-roxadustat-for-anemia