Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX), a company focused on
bringing innovative medicines to people with kidney disease, today
presented new real world data from a large dialysis provider that
showed Auryxia® (ferric citrate) tablets, when dosed as a phosphate
binder, reduced erythropoiesis-stimulating agent (ESA) and
intravenous iron (IV iron) use, while maintaining hemoglobin levels
in patients on dialysis. These data were presented today in a
poster at the American Society of Nephrology’s (ASN) 2017 Kidney
Week taking place in New Orleans.
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 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.
“Conclusions in this poster confirm the
reductions in the use of IV iron and ESA observed in our pivotal
Phase 3 study in patients with CKD on dialysis published in the
July 2014 issue of the Journal of the American Society of
Nephrology,” said John Neylan, M.D., chief medical officer of Keryx
Biopharmaceuticals. “These real world insights from a large number
of patients improve the understanding of Auryxia and further
demonstrate the ability of Auryxia to treat hyperphosphatemia and
the value this medicine can bring to payers, physicians and
patients.”
About the Real World DataPoster
presentation (#SA-PO825), titled: “The effect of ferric citrate on
IV iron, ESA utilization and laboratory parameters in real-world
dialysis practice.”
Data in this poster are from a retrospective
study that evaluated health records and pharmacy claims for 2,395
adults on dialysis who initiated treatment with Auryxia as a
phosphate binder during an 18-month period from January 2015 to
July 2016. The study evaluated changes in laboratory parameters and
change in IV iron and ESA utilization before and after Auryxia
initiation. Outcomes were analyzed in three sequential follow-up
treatment periods compared to baseline: follow-up 1: 0-91 days
(n=926); follow-up 2: 92-182 days (n=419); and follow up 3: 183-274
days (n=200). Prior to Auryxia initiation, 91 percent of patients
were previously on a phosphate binder and switched or added Auryxia
to their treatment regimen. Results from the study confirmed the
known profile of Auryxia to control serum phosphorus levels in
dialysis patients and its ability to increase iron stores and
reduce utilization of IV iron and ESAs. Real-world data in the
poster include:
Mean Serum Phosphorus Levels:
Mean serum phosphorus decreased from ~6.7 mg/dL at baseline to ~6.4
mg/dL in each of the follow up periods. At baseline, 25 percent of
patients had serum phosphorus <5.5 mg/dL. After each of the
follow-up periods at three, six and nine months, 34 percent
(p<0.001), 40 percent (p<0.001), 36 percent (p=0.185) of
patients treated with Auryxia achieved serum phosphorus <5.5
mg/dL, respectively. In addition, the overall phosphate binder pill
burden decreased by >2 pills/day (p<0.001) in each follow-up
treatment period.
Hemoglobin and Iron Parameters:
Hemoglobin and iron parameter levels increased steadily from
baseline to nine months (Table 1). Despite reductions in IV iron
and ESA utilization, hemoglobin and iron parameters improved within
3 months of ferric citrate initiation in patients on
dialysis.
|
Table 1: Change in Hemoglobin and Iron
Parameters |
|
Treatment Follow-up 10-91 days
(n=926) |
Treatment Follow-up 292-182 days
(n=419) |
Treatment Follow-up 3183-274 days
(n=200) |
Baseline mean hemoglobin (g/dL) |
10.75 |
10.73 |
10.78 |
End of follow-up mean hemoglobin (g/dL) |
10.87 |
10.90 |
11.11 |
p-values |
0.009 |
0.011 |
0.001 |
Baseline mean TSAT (%) |
30.0 |
29.8 |
29.0 |
End of follow-up mean TSAT (%) |
33.4 |
34.4 |
36.4 |
p-values |
<0.001 |
<0.001 |
<0.001 |
Baseline mean ferritin (ng/dL) |
644 |
638 |
620 |
End of follow-up mean ferritin (ng/dL) |
720 |
770 |
863 |
p-values |
<0.001 |
<0.001 |
<0.001 |
|
|
|
|
IV Iron and ESA Utilization:
With Auryxia treatment, overall IV iron and ESA use decreased in
each follow-up period (Table 2). Additionally, for patients who
received Auryxia for a full nine months (n=200) there was a steady
decline in median IV iron and ESA dose during each of the follow-up
periods. The median cumulative dose of IV iron declined by 20
percent, 50 percent and 60 percent at follow-up 1, follow-up 2 and
follow-up 3, respectively; and the median ESA cumulative dose
declined by 13 percent, 16 percent and 27 percent,
respectively.
|
Table 2: Change in IV Iron and ESA
Utilization |
|
Treatment Follow-up 10-91 days
(n=926) |
Treatment Follow-up 292-182 days
(n=419) |
Treatment Follow-up 3183-274 days
(n=200) |
% of patients with no IV Iron use (at baseline) |
22 |
21 |
16 |
% of patients with no IV Iron use (at end of follow-up
period) |
27 |
31 |
37 |
% of patients with no ESA use(at baseline) |
11 |
11 |
13 |
% of patients with no ESA use(at end of follow-up period) |
13 |
14 |
16 |
|
|
|
|
About Auryxia® (ferric citrate)
tabletsAuryxia (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 adults
with chronic kidney disease 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, 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.
Forward Looking Statements Some
of the statements included in this press release, particularly
those regarding the commercialization and ongoing clinical
development of Auryxia and the submission of an sNDA to the FDA to
expand the label of ferric citrate to include the treatment of IDA
in adults with stage 3-5 NDD-CKD and the potential approval in this
indication and the impact thereof on Keryx, 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; whether we can maintain our operating expenses to
projected levels while continuing our current clinical, regulatory
and commercial activities; the risk that the FDA may not concur
with our interpretation of our Phase 3 study results in 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; our
ability to continue to supply Auryxia to the market; 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, 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: 617.466.3519amy.sullivan@keryx.com
Lora PikeSenior Director, Investor Relations
& Corporate CommunicationsT:
617.466.3511lora.pike@keryx.com
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