Keryx Biopharmaceuticals’ drug Auryxia (ferric citrate) will undergo a review by the U.S. Food and Drug Administration (FDA) to expand its clinical indications to include non-dialysis dependent chronic kidney disease (NDD-CDK) patients with iron-deficiency anemia (IDA).
The supplemental New Drug Application (sNDA) was accepted for review by the FDA in March, and the review is expected to be completed by Nov. 6, 2017.
Keryx is a biopharma that specializes in innovative medicines for kidney diseases. Auryxia is an oral medication that is used to control serum phosphorous levels. It is currently approved in the U.S. for patients with end-stage renal disease requiring dialysis.
“Iron deficiency anemia is a common complication in people with non-dialysis dependent chronic kidney disease, yet currently there are no FDA-approved oral medicines to treat this debilitating disease,” John Neylan, MD, senior vice president and chief medical office of Keryx, said in a press release.
“Acceptance of the sNDA filing not only brings us one step closer to providing this medicine to patients in need, it is an important milestone for the company and our efforts to leverage ferric citrate’s mechanism of action,” he said.
According to Keryx, the majority of NDD-CKD patients with IDA are not adequately treated for their iron deficiency with currently available oral supplements. The company estimates that of the 1.7 million Americans with NDD-CKD, approximately 650,000 are treated for IDA while another 250,000 to 400,000 could have IDA but are not currently treated. Therefore, new treatment options for these patients are necessary.
Data from a Phase 3 trial that included 234 adults with stage 3-5 NDD-CKD was included in the sNDA. This study shows that treatment with Auryxia significantly increased hemoglobin levels in most (52.1%) of patients. The most common side effects associated with Auryxia include diarrhea, nausea, vomiting, and constipation.
Auryxia works by binding with dietary phosphate in the gastrointestinal (GI) tract and precipitates as ferric phosphate. Some of the drug remains unbound and has been shown to increase serum iron parameters, including ferritin and transferrin saturation (TSAT). This leads to iron absorption. Physicians should closely monitor iron levels to avoid iron overload in patients treated with Auryxia.
The use of Auryxia in NDD-CKD patients with IDA is still preliminary. It has not been deemed safe or effective and future studies are still needed.