Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX), a biopharmaceutical
company focused on bringing innovative medicines to people with
renal disease, today announced case study data, which showed that
Auryxia® (ferric citrate) lowered and maintained serum phosphorus
levels in chronic kidney disease (CKD) patients on dialysis. These
data were presented in a poster presentation today at the American
Society of Nephrology’s 2016 Kidney Week taking place in Chicago.
Auryxia (ferric citrate) is currently indicated for the control
of serum phosphorus levels in patients with CKD on dialysis.
“Data from this poster at ASN provide the first real-world
evidence of the effect of Auryxia in treating hyperphosphatemia in
people on dialysis,” said John Neylan, M.D., chief medical officer
of Keryx Biopharmaceuticals. “With Auryxia available again at
pharmacies, we are pleased to be able to provide these data from
the everyday practice setting that support Auryxia’s profile.”
About the Case Study Retrospective DataData
from a retrospective chart review of 92 patients were collected by
seven health care providers at multiple clinics across the U.S.
Patients with CKD on dialysis who had been taking Auryxia for the
control of serum phosphorus for a minimum of six months were
selected to participate. The retrospective data demonstrate
Auryxia’s effect in dialysis-dependent chronic kidney disease
patients in routine clinical practice.
Of the 92 patient charts, 25 people were receiving peritoneal
dialysis and 62 people were receiving in-center hemodialysis as
part of routine clinical care. At the time of Auryxia treatment
initiation, 21 patients (23%) were naïve to phosphate binders,
while the remaining were treated with sevelamer (n = 37, 52%),
calcium-based binders (n = 20, 28%), sevelamer + calcium (n = 10,
14%), or another binder (n = 4, 6%). Data collected included
patients who took Auryxia for at least six months.
Case Study Data:Target phosphate
level: 22 percent of patients were within the KDOQI
guidelines range of 3.5 mg/dL to 5.5 mg/dL before taking one dose
of Auryxia (i.e. baseline). At one and six months of treatment with
Auryxia, 48 percent and 65 percent of patients, respectively,
achieved serum phosphorus levels within the KDOQI guideline target
range.
Mean serum phosphorus levels: At
baseline, patients had a mean serum phosphorus level of 6.55 mg/dL,
which was lowered to 5.41 mg/dL after six months of treatment with
Auryxia. The reduction in serum phosphorus levels were comparable
in patients taking Auryxia who switched from sevelamer and/or
calcium and in patients new to binders.
Daily tablets: At baseline, patients were
taking a mean of 11.7 tablets per day on their prior phosphate
binder(s). Patients who stopped their prior phosphate binder(s) and
switched to Auryxia had a mean tablet burden of 7.3 tablets per day
at month six of treatment with Auryxia.
Iron biomarker levels (TSAT and Ferritin): At
baseline, mean hemoglobin, ferritin, and transferrin saturation
were 10.6 g/dL, 734 ng/mL, and 27.1 percent, respectively. These
levels increased by month three and were maintained through month
six. After six months of treatment with Auryxia, these levels were
11.1 g/dL, 947 ng/mL, and 37 percent, respectively.
Discontinuations: Five patients discontinued
treatment after three months of treatment: three received kidney
transplants, one discontinued dialysis and one was lost to
follow-up.
About Auryxia 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 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.
Auryxia binds with dietary phosphate in the GI tract and
precipitates as ferric phosphate. The unbound portion of Auryxia
has been shown to increase serum iron parameters including ferritin
and transferrin saturation (TSAT). Iron absorption from Auryxia may
lead to excessive elevations in iron stores. Accordingly,
physicians should assess and monitor iron parameters before
starting and while on Auryxia, and may need to decrease or
discontinue IV iron for these patients. The most common adverse
events for Auryxia treated patients were gastrointestinal related,
including diarrhea, nausea, vomiting and constipation. For more
information about Auryxia and the U.S. full prescribing
information, visit www.Auryxia.com.
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.
For Full Prescribing Information for Auryxia, please
visit http://auryxia.com/important-safety-information/
Forward Looking Statements Some of the
statements included in this press release, particularly those
regarding the commercialization and ongoing clinical development 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: whether we can increase adoption of
Auryxia in patients with CKD on dialysis; the risk that the FDA may
not concur with our interpretation of our Phase 3 study results in
non-dialysis dependent (NDD) CKD, supportive data, conduct of the
studies, or any other part of our regulatory submission and could
ultimately deny approval of ferric citrate for the treatment of IDA
in adults with stage 3-5 NDD-CKD; the risk that if approved for use
in NDD-CKD that we may not be able to successfully market Auryxia
for use in this indication; 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.
About Keryx Biopharmaceuticals, Inc. Keryx
Biopharmaceuticals, with headquarters in Boston, is focused on
bringing innovative medicines to market for people with renal
disease. In December 2014, the company launched its first
FDA-approved medicine, Auryxia® (ferric citrate) in the United
States. In January 2014, ferric citrate was approved for use
in Japan, where it is being marketed as Riona® by Keryx's Japanese
partner, Japan Tobacco Inc. and Torii Pharmaceutical Co. Ltd. In
September 2015, the European Commission granted European market
authorization for Fexeric® (ferric citrate coordination complex).
For more information about Keryx, please visit www.keryx.com.
KERYX BIOPHARMACEUTICALS CONTACTS:
Amy Sullivan
Vice President, Strategic Operations and Corporate Affairs
T: 617.466.3519
amy.sullivan@keryx.com
Lora Pike
Senior Director, Investor Relations
T: 617.466.3511
lora.pike@keryx.com
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