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# Reject Auryxia sNDA: Vifor Fresenius
- URL: https://www.fdaweb.com/reject-auryxia-snda-vifor-fresenius/
- Published: 2017-07-11T12:00:00.000Z
- Updated: 2026-09-14T22:33:32.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139100

Vifor Fresenius Medical Care Renal Pharma is asking FDA to refuse to approve a Keryx Biopharmaceuticals sNDA to add an indication for its Auryxia “because of multiple, serious safety concerns.” The company markets several products that could be impacted if the sNDA is approved. A 6/30 [petition](https://www.regulations.gov/document?D=FDA-2017-P-4023-0001&ref=fdaweb.com) says the sNDA seeks to add an indication for treating iron deficiency anemia in non-dialysis dependent chronic kidney disease patients who are intolerant to or had an inadequate response to oral iron supplement. Auryxia is currently approved for controlling serum phosphorous levels in dialysis dependent chronic kidney disease patients.

According to Fresenius, the clinical data submitted by Keryx to support its sNDA do not support the safety of long-term use of Auryxia to treat iron deficiency anemia in the chronic kidney disease patients and then treat dialysis dependent patients for hyperphosphatemia.

Inclusion of the new indication on the labeling “would be highly misleading, and would result in the inclusion of two indications for distinct patient populations, each with a Warning that relates to the other indication,” the petition says. “Such a label is unprecedented, potentially confusing, and unacceptable as it may result in a failure to adequately monitor phosphorous levels and iron stores, posing significant safety risks for patients.”

The petition says that while the study Keryx submitted in support of its sNDA shows the drug has an effect on hemoglobin levels, it does not address significant safety concerns raised by giving a phosphate binder to patients with non-dialysis dependent chronic kidney disease. “In fact,” it says, “the recently updated treatment guidelines … advises against use of phosphate binders in patients whose phosphorous levels are in the normal range, because of the potential for adverse impacts on mineral and bone metabolism and the cardiovascular system. Moreover, significant concerns remain about long-term adverse impacts stemming from Auryxia’s role in increasing ferritin and transferrin saturation.”

The company suggests that FDA require a separate NDA for the new indication, which would require adequate preclinical and clinical data to support safety and efficacy.