Keryx Biopharmaceuticals Announces Late-breaking Ferric Citrate Abstract Accepted for Presentation at the 55th ERA-EDTA Congr...
April 19 2018 - 09:00AM
Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX), a biopharmaceutical
company focused on bringing innovative medicines to people with
kidney disease, today announced that data from an investigator
sponsored trial that evaluated ferric citrate (Auryxia®) use in
patients with advanced chronic kidney disease (CKD) will be
presented at the 55th European Renal Association-European Dialysis
and Transplant Association (ERA-EDTA) Congress taking place in
Copenhagen from May 24-27, 2018.
The late-breaking abstract, “Randomized Trial of
the Effects of Ferric Citrate in Patients with Advanced Chronic
Kidney Disease,” is scheduled for presentation on Friday, May 25,
2018 at 11:45 a.m. Geoffrey Block, M.D., Director of Clinical
Research at Denver Nephrology and Principal Investigator of the
trial, will present the data. The abstract is now available on the
ERA-EDTA website.
The ERA-EDTA includes over 7,000 physician
members internationally and its objective is the advancement of
medical science and clinical work in nephrology, dialysis, renal
transplantation, hypertension and other related topics.
About Auryxia® (ferric citrate)
tabletsAuryxia (ferric citrate) was approved by the U.S.
Food and Drug Administration (FDA) on September 5, 2014 for the
control of serum phosphorus levels in adult patients with chronic
kidney disease on dialysis and approved by the FDA on November 6,
2017 for the treatment of iron deficiency anemia in adult patients
with chronic kidney disease not on dialysis. Auryxia tablets were
designed to contain 210 mg of ferric iron, equivalent to 1 gram of
ferric citrate, and offers convenient mealtime dosing. The starting
dose of Auryxia for the treatment of hyperphosphatemia for patients
on dialysis is six tablets per day (two per meal) and for the
treatment of iron deficiency anemia in patients not on dialysis is
three tablets per day (one per meal). For more information about
Auryxia and the U.S. full prescribing information, please visit
www.Auryxia.com.
IMPORTANT U.S. SAFETY INFORMATION FOR
AURYXIA® (ferric citrate)
CONTRAINDICATION
AURYXIA® (ferric citrate) is contraindicated in
patients with iron overload syndromes, e.g., hemochromatosis.
WARNINGS AND PRECAUTIONS
- Iron Overload: Increases in serum ferritin and
transferrin saturation (TSAT) were observed in clinical trials with
AURYXIA in patients with chronic kidney disease (CKD) on dialysis
treated for hyperphosphatemia, which may lead to excessive
elevations in iron stores. Assess iron parameters prior to
initiating AURYXIA and monitor while on therapy. Patients receiving
concomitant intravenous (IV) iron may require a reduction in dose
or discontinuation of IV iron therapy.
- Risk of Overdosage in Children Due to Accidental
Ingestion: Accidental ingestion and resulting overdose of
iron-containing products is a leading cause of fatal poisoning in
children under 6 years of age. Advise patients of the risks
to children and to keep AURYXIA out of the reach of children.
ADVERSE REACTIONS
Most common adverse reactions with AURYXIA
were:
- Hyperphosphatemia in CKD on Dialysis: Diarrhea (21%),
discolored feces (19%), nausea (11%), constipation (8%), vomiting
(7%) and cough (6%)
- Iron Deficiency Anemia in CKD Not on Dialysis: Discolored feces
(22%), diarrhea (21%), constipation (18%), nausea (10%), abdominal
pain (5%) and hyperkalemia (5%)
SPECIFIC POPULATIONS
- Pregnancy and Lactation: There are no
available data on AURYXIA use in pregnant women to inform a
drug-associated risk of major birth defects and miscarriage.
However, an overdose of iron in pregnant women may carry a risk for
spontaneous abortion, gestational diabetes and fetal
malformation. Data from rat studies have shown the transfer
of iron into milk, hence, there is a possibility of infant exposure
when AURYXIA is administered to a nursing woman.
To report suspected adverse reactions, contact
Keryx Biopharmaceuticals at 1-844-445-3799.
Please click here to view the
Full Prescribing Information for Auryxia.
About Keryx Biopharmaceuticals,
Inc.Keryx Biopharmaceuticals, Inc., headquartered 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. This
dedication has resulted in two FDA-approved indications for Keryx’s
first medicine, Auryxia® (ferric citrate) tablets. For more
information about Keryx, please visit www.keryx.com.
Forward-looking Statements Some
of the statements included in this press release may be
forward-looking statements that involve a number of risks and
uncertainties. For those statements, we claim the protection of the
safe harbor for forward-looking statements contained in the Private
Securities Litigation Reform Act of 1995. Among the factors that
could cause our actual results to differ materially are the
following: the benefit seen by patients using Auryxia outside the
clinical setting; our ability to successfully market Auryxia as
well as whether we can increase adoption of Auryxia in patients
with CKD on dialysis and successfully launch Auryxia for the
treatment of iron deficiency anemia in patients with chronic kidney
disease, not on dialysis; whether we can maintain our operating
expenses to projected levels while continuing our current clinical,
regulatory and commercial activities; our ability to continue to
supply Auryxia to the market; the risk that increased utilization
by Medicare Part D subscribers will increase our gross-to-net
adjustment greater than we anticipate; and other risk factors
identified from time to time in our reports filed with the
Securities and Exchange Commission. Any forward-looking statements
set forth in this press release speak only as of the date of this
press release. We do not undertake to update any of these
forward-looking statements to reflect events or circumstances that
occur after the date hereof. This press release and prior releases
are available at http://www.keryx.com. The information found on our
website is not incorporated by reference into this press release
and is included for reference purposes only.
KERYX BIOPHARMACEUTICALS CONTACTAmy Sullivan,
SVP, Corporate AffairsT: 617.466.3519amy.sullivan@keryx.com
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