Keryx Biopharmaceuticals Announces Publication of Data from the Phase 3 Trial of Auryxia® (ferric citrate) for Iron Deficien...
April 04 2018 - 8:00AM
Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX), a biopharmaceutical
company focused on bringing innovative medicines to people with
kidney disease, today announced the publication of a post-hoc
analysis of Auryxia phase 3 trial data for iron deficiency anemia
in adult patients with chronic kidney disease (CKD), not on
dialysis, in the online issue of the American Journal of
Hematology.
The article, entitled “Hemoglobin Response to
Ferric Citrate in Patients with Non-dialysis-dependent Chronic
Kidney Disease and Iron Deficiency Anemia,” describes associations
of baseline demographic, clinical and laboratory variables with
change in hemoglobin in ferric citrate-treated patients. In the
phase 3 study, 234 patients were randomized to receive ferric
citrate (n=117) or placebo (n=117). The full results of the phase 3
study were published in January 2017 in the Journal of the American
Society of Nephrology.1 This post-hoc analysis assessed the
intent-to-treat population (ferric citrate, n=117; placebo, n=115).
Baseline characteristics were similar across treatment groups.
Results of this multivariable regression analysis show the
following variables were associated with greater hemoglobin
increases from baseline at 16 weeks: ferric citrate treatment
(p<.0001), lower baseline hemoglobin (p=.0160), higher serum
albumin (p=.0007), lower intact fibroblast growth factor 23 (FGF23)
(p=.0024), and lower transferrin saturation (TSAT) (p=.0189).
Treatment interactions were observed for TSAT and ferritin
only.
“While patients with lower baseline measures of
TSAT/ferritin values experienced a greater hemoglobin increase than
those with higher baseline measures of iron storage, hemoglobin
increases were also clinically significant among those with higher
baseline TSAT/ferritin values, indicating that Auryxia is
efficacious over a wide range of patients with CKD, not on
dialysis,” said John Neylan, M.D., chief medical officer of Keryx
Biopharmaceuticals. “These findings support the current KDIGO
treatment guidelines that recommend a trial of oral iron in
patients with iron deficiency anemia and chronic kidney
disease.”
About Iron Deficiency Anemia in People
with Chronic Kidney Disease, not on Dialysis One out of
every seven adults in the U.S. has chronic kidney disease. This
disease carries a significant burden with complex issues requiring
many different medications. More than half of the 30 million people
in the United States living with CKD are estimated to be iron
deficient2 and a common complication of CKD is iron deficiency
anemia. Iron is an essential mineral for the human body and is
typically obtained from the diet. It is a critical component of
human blood as it is necessary to make healthy red blood cells.
People with chronic kidney disease often have anemia as a result of
insufficient iron (called iron deficiency anemia) and don’t produce
enough hemoglobin, the component of the red blood cell that carries
oxygen throughout the body. Iron deficiency anemia can negatively
impact a patient’s quality of life and is associated with
cardiovascular complications and increased mortality risk.3 The
prevalence and severity of iron deficiency anemia increases as
kidney disease progresses.4
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, particularly
those regarding the post-hoc analysis and the effectiveness of
Auryxia, 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 of the clinical setting; as well as our ability to
successfully market Auryxia and 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.
References1
Fishbane S, et al. Clin J Am Soc Nephrology 2017
Jun:28(6):1851-1858;2 Fishbane S, et al. Clin J Am Soc
Nephrology 2009;4:57-613 Lefebvre P, et al. Curr Med Res Opin.
2006;22:1929-1937; Drueke TB, et al. N Engl J Med. 2006;
355:2071-2084; Herzog CA, et al. J Card Fail. 2004;10:467-472;
Kovesdy CP, et al. Kidney Int. 2006;69:560-546; Silverberg DS, et
al. Blood Purif. 2003;21:124-1304 Stauffer ME, et al. PLoS One.
2014;9:e84943
KERYX BIOPHARMACEUTICALS CONTACTAmy
SullivanSenior Vice President, Corporate AffairsT:
617.466.3519amy.sullivan@keryx.com
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