Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX), a company focused on
bringing innovative medicines to people with kidney disease, today
announced that the U.S. Food and Drug Administration (FDA) has
approved Auryxia for an additional indication. The approval is
for the treatment of iron deficiency anemia in adults with chronic
kidney disease (CKD), not on dialysis. Auryxia was originally
approved in September 2014 for the control of serum phosphorus
levels in people with chronic kidney disease who require dialysis.
With the new indication, millions of people
living with chronic kidney disease have the potential to benefit
from treatment with Auryxia. This medication is available today in
pharmacies and covered broadly by Medicare Part D and commercial
insurance providers in the United States.
“More than half of the approximate 30 million
people in the United States living with chronic kidney disease are
iron deficient, and yet, this is the only tablet that has been
developed and approved specifically to address iron deficiency
anemia in these patients, who are not on dialysis,” said Steven
Fishbane, M.D., chief, division of kidney diseases and
hypertension, department of medicine, Northwell Health in Great
Neck, New York. “Starting today, physicians can prescribe an oral
iron medicine to help people living with this condition, the
majority of whom are not being optimally treated.”
“We are pleased with the broad indication
permitted by the FDA, as a first-line treatment option for adults
with iron deficiency anemia and chronic kidney disease, not on
dialysis,” said John Neylan, M.D., senior vice president and chief
medical officer of Keryx Biopharmaceuticals. “Physicians and their
patients now have a new treatment option to help manage a serious
complication of this complex disease.”
Auryxia’s supplemental new drug application
(sNDA) approval was based on results from a 24-week placebo
controlled Phase 3 clinical trial in 234 adults with stage 3-5
non-dialysis dependent chronic kidney disease. Patients enrolled in
the trial had hemoglobin levels between 9.0 g/dL and 11.5 g/dL and
were intolerant to or had an inadequate response to prior treatment
with oral iron supplements. The starting dose in the study was
three tablets per day taken with meals; the mean dose was five
tablets per day. Importantly, during the study, patients were not
allowed to receive any intravenous (IV) or oral iron, or
erythropoiesis-stimulating agents (ESAs). In the study, treatment
with Auryxia demonstrated significant increases in hemoglobin
levels of >1 g/dL at any point during the 16-week efficacy
period for the majority of patients (52.1 percent, n=61/117
compared to 19.1 percent, n=22/115 in the placebo group), a
clinically meaningful result. In the trial, ferric citrate was
generally well tolerated and adverse events were consistent with
its known safety profile. The most commonly reported adverse events
in the Phase 3 study were diarrhea (21%), constipation (19%),
discolored feces (15%), nausea (11%), abdominal pain (6%) and
hyperkalemia (7%). Results were published January 2017 in the
online issue of the Journal of the American Society of Nephrology
(JASN).
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. 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.2 Based
on market research, Keryx estimates that nephrologists currently
treat 650,000 people for iron deficiency anemia who have chronic
kidney disease and are not on dialysis. There are estimated to be
an additional 250,000 – 400,000 people under the care of a
nephrologist who have chronic kidney disease and iron deficiency
anemia but are not treated today. The prevalence and severity of
iron deficiency anemia increases as kidney disease progresses.3
About Auryxia® (ferric citrate)
tabletsAuryxia (ferric citrate) was approved by the U.S.
Food and Drug Administration on September 5, 2014 for the control
of serum phosphorus levels in adults with chronic kidney
disease on dialysis and approved on November 6, 2017 for the
treatment of iron deficiency anemia in adults 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.
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: 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.
Conference Call
InformationKeryx will host an investor conference call
today at 8:00 a.m. ET to discuss the FDA approval of Auryxia's
additional indication and third quarter 2017 financial results. To
participate in the conference call, please call 1-(888) 396-2320
(U.S.), 1-(774) 264-7560 (outside the U.S.), call-in ID: 2193619.
The call will also be webcast which will be accessible through the
Investors section of the company's website at www.keryx.com. The
audio replay will be available at http://www.keryx.com for a period
of 15 days after the call.
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. 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.
References
1 Fishbane S, et al. Clin J Am Soc
Nephrology 2009;4:57-61
2 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;21:124-130
3 Stauffer ME, et al. PLoS One.
2014;9:e84943
INVESTORS:KERYX
BIOPHARMACEUTICALS CONTACTSAmy 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
MEDIA:SALUTEMLindsay CangemiT:
312-240-3379Lindsay.cangemi@salutemcomms.com
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