FDA declines to approve roxadustat for treatment of anaemia of chronic kidney disease
The FDA has requested an additional clinical trial in both the non-dialysis dependent and dialysis-dependent adult patient populations on the safety of this first-in-class inhibitor of HIF prolyl hydroxylase that activates a response when blood oxygen levels are low.
Source:
PharmaTimes
SPS commentary:
In June 2021, the European CHMP recommended approval of roxadustat (Evrenzo) for the treatment of anaemia symptoms in patients with chronic kidney disease.