Citing safety concerns, Fresenius asked the FDA to withhold approval for an additional indication for Keryx’s sNDA for Auryxia.
In a citizen petition, the company asked the agency to deny an sNDA Keryx submitted in March seeking an additional indication for Auryxia, which is currently indicated for the control of serum phosphorus levels in chronic kidney disease patients on dialysis. The proposed additional indication is for treatment of iron deficiency anemia in chronic, non-dialysis patients.
Keryx presents significant safety risks to users’ iron stores, and this is reflected in its labeling, according to Fresenius. The FDA should not consider the additional indication until Keryx submits a separate NDA, with clinical data demonstrating that the drug is safe to use in the long term, the petition says.