Drug formerly known as Zerenex gets approval following Phase 3 clinical trials
The US Food and Drug Administration has approved a new drug to treat dialysis patients with chronic kidney disease.
Ferric Citrate, developed by Keryx Biopharmaceuticals and formerly known as Zerenex, was approved to help control serum phosphorous levels in chronic kidney disease patients on dialysis.
The approval came after Phase 3 clinical trials demonstrated that treatment with ferric citrate “effectively reduced serum phosphorus levels to well within the KDOQI guidelines range of 3.5mg/dL to 5.5 mg/dL,” according to a statement from the company. The study also showed that the drug increased ferritin and transferrin saturation compared to patients taking Renvela and/or Phoslo. Some adverse events during the study included diarrhea, nausea, vomiting and constipation.
“I believe that Ferric Citrate offers clear benefits to patients and represents a new way for physicians to manage hyperphosphatemia,” noted lead investigator Julia Lewis, MD, a nephrologist and professor of medicine at Vanderbilt University medical Center. “Given Ferric Citrate’s pharmacodynamics properties that lead to increases in iron stores, physicians should assess and monitor iron parameters and may need to reduce the dose or discontinue IV iron therapy.”
The statement from the company noted that as part of the approval process they were informed that the name Zerenex had been rescinded. “Keryx believes the Company will have an approved brand name on or prior to launch, although a brand name is not a pre-requisite for the launch of an FDA-approved drug.”