Keryx Biopharmaceuticals Announces Presentations of New Data at the American Society of Nephrology Kidney Week 2017 Annual Meeting
One of the three abstracts was accepted as an oral presentation. It describes post-hoc analyses of data from the Phase 3 study of ferric citrate in iron deficiency anemia and chronic kidney disease examining the effect of ferric citrate on fibroblast growth factor (FGF23), a bone derived hormone important for phosphate homeostasis and associated with chronic kidney disease progression. The other two abstracts were accepted as poster presentations. One describes Phase 3 data of ferric citrate in iron deficiency anemia and chronic kidney disease examining the effect of ferric citrate on serum phosphorus in patients with normal and elevated baseline phosphorus levels. The other describes real-world outcomes data collected from a large U.S. dialysis provider in people on dialysis treated with Auryxia as a phosphate binder for up to nine months.
The three accepted abstracts are listed below and are now accessible online on ASN’s conference website at https://www.asn-online.org/education/kidneyweek/archives/.
Ferric Citrate Reduced FGF23 in Patients with Non-Dialysis Dependent Chronic Kidney Disease (NDD-CKD) and Iron Deficiency Anemia (IDA) Irrespective of the Change in Serum Phosphate (P)
Abstract No: TH-OR038
Ferric Citrate Lowered Serum Phosphate Only When Elevated in Patients with Nondialysis-Dependent (NDD) CKD and Iron Deficiency Anemia (IDA)
Abstract No: TH-PO514
The Effect of Ferric Citrate on IV Iron, ESA Utilization and Laboratory Parameters in Real-World Dialysis Practice
Abstract No: SA-PO825
About Auryxia® (ferric citrate) tablets
Auryxia (ferric citrate) was approved by the
Use of ferric citrate in patients with IDA, NDD-CKD, as highlighted above, is investigational and has not been determined to be safe or efficacious.
IMPORTANT U.S. SAFETY INFORMATION FOR AURYXIA® (ferric citrate)
Contraindication: Patients with iron overload syndrome, e.g. hemochromatosis, should not take Auryxia®.
Iron Overload: Iron absorption from Auryxia may lead to increased iron in storage sites. Iron parameters should be monitored prior to and while on Auryxia. Patients receiving IV iron may require a reduction in dose or discontinuation of IV iron therapy.
Accidental Overdose of Iron: Accidental overdose of iron containing products is a leading cause of fatal poisoning in children under 6 years of age. Keep Auryxia away from children as it contains iron. Call a poison control center or your physician in case of an accidental overdose in a child.
Patients with Gastrointestinal Bleeding or Inflammation: Safety has not been established for these patients.
Adverse Events: The most common adverse events with Auryxia were diarrhea (21%), nausea (11%), constipation (8%), vomiting (7%) and cough (6%). Gastrointestinal adverse reactions were the most common reason for discontinuing Auryxia (14%). Auryxia contains iron and may cause dark stools, which is considered normal with oral medications containing iron.
Drug Interactions: Doxycycline should be taken at least 1 hour before Auryxia. Ciprofloxacin should be taken at least 2 hours before or after Auryxia.
KERYX BIOPHARMACEUTICALS CONTACTS:
Senior Vice President, Corporate Affairs
Senior Director, Investor Relations & Corporate Communications
Source: Keryx Biopharmaceuticals, Inc.