Keryx Biopharmaceuticals Announces Presentations of New Data at the American Society of Nephrology Kidney Week 2017 Annual Me...
October 13 2017 - 10:11AM
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/.
Oral
Presentation
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. CTFirst Author: Geoffrey Block, M.D.Abstract No: TH-OR038
Poster Presentations
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. CTFirst 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
PracticeDate/Time: Saturday, November 4, 2017 from 10:00
a.m. to 12:00 p.m. CTFirst 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.
KERYX BIOPHARMACEUTICALS
CONTACTS:Amy SullivanSenior Vice President, Corporate
AffairsT: 617.466.3519 amy.sullivan@keryx.com
Lora PikeSenior Director, Investor Relations
& Corporate CommunicationsT:
617.466.3511lora.pike@keryx.com
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