BOSTON, Oct. 13, 2017 (GLOBE NEWSWIRE) — Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX), a company focused on bringing innovative medicines to people with kidney disease, today announced that three abstracts for Auryxia® (ferric citrate) tablets have been accepted for presentation at the 2017 American Society of Nephrology (ASN) Annual Meeting being held October 31 to November 5, 2017 in New Orleans.
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.
Auryxia is FDA-approved as a phosphate binder indicated for the control of serum phosphorus levels in adult patients with chronic kidney disease on dialysis. Keryx is seeking to expand the indication for Auryxia to include the treatment of iron deficiency anemia (IDA) in patients with non-dialysis dependent chronic kidney disease (NDD-CKD). A supplemental new drug application is under review by the U.S. FDA, with a Prescription Drug User Fee Act (PDUFA) target action date of November 6, 2017.
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)
Date/Time: Thursday, November 2, 2017 at 5:54 p.m. CT
First Author: Geoffrey Block, M.D.
Abstract No: TH-OR038
Ferric Citrate Lowered Serum Phosphate Only When Elevated in Patients with Nondialysis-Dependent (NDD) CKD and Iron Deficiency Anemia (IDA)
Date/Time: Thursday, November 2, 2017 from 10:00 a.m. CT to 12:00 p.m. CT
First Author: Geoffrey Block, M.D.
Abstract No: TH-PO514
The Effect of Ferric Citrate on IV Iron, ESA Utilization and Laboratory Parameters in Real-World Dialysis Practice
Date/Time: Saturday, November 4, 2017 from 10:00 a.m. to 12:00 p.m. CT
First Author: Csaba Kovesdy, M.D.
Abstract No: SA-PO825
About Auryxia® (ferric citrate) tablets
Auryxia (ferric citrate) was approved by the U.S. Food and Drug Administration on September 5, 2014 and is indicated in the U.S. for the control of serum phosphorus levels in patients with CKD on dialysis. The U.S. approval of Auryxia was based on data from the company’s Phase 3 registration program in dialysis patients. In the Phase 3 clinical trials, Auryxia effectively reduced serum phosphorus levels to within the KDOQI guidelines range of 3.5 to 5.5 mg/dL. For more information about Auryxia and the U.S. full prescribing information, please visit www.Auryxia.com.
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.
About Keryx Biopharmaceuticals, Inc.
Keryx Biopharmaceuticals, Inc., with headquarters in Boston, Massachusetts, is focused on the development and commercialization of innovative medicines that provide unique and meaningful advantages to people with kidney disease. The Keryx team consists of approximately 200 committed people working with passion to advance the care of people with this complex disease. In September 2014, the U.S. Food and Drug Administration approved Keryx’s first medicine, Auryxia® (ferric citrate) tablets. For more information about Keryx, please visit www.keryx.com.
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