Ferumoxytol Results in Significant Hemoglobin Increases in Adult Iron
Deficiency Anemia Patients With Abnormal Uterine Bleeding Who Had Failed or
Could Not Tolerate Oral Iron Therapy
Sub-Group Analysis of a Phase III, Randomized, Placebo-Controlled Trial Being
Presented Today in a Poster Session at the American College of Obstetrics and
Gynecology Annual Meeting
LEXINGTON, Mass., May 6, 2013 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc.
(Nasdaq:AMAG) today announced that a new sub-group analysis from IDA-301, a
phase III, randomized, placebo-controlled clinical trial, will be presented
today at the first poster session of the American College of Obstetrics and
Gynecology (ACOG) annual meeting in New Orleans, Louisiana. In the full
IDA-301 study, 608 adult patients with iron deficiency anemia (IDA) who had
failed or could not tolerate oral iron were treated with ferumoxytol and 200
received placebo, with the demographics and all baseline parameters well
balanced between the two treatment groups. The sub-group analysis being
presented today at ACOG is based on 344 patients in IDA-301 with abnormal
uterine bleeding (AUB), the most frequent underlying cause for IDA in this
study, with 260 AUB patients randomized to ferumoxytol and 84 to placebo.
IDA-301 was a randomized, double-blind, placebo-controlled multicenter trial
designed to compare the safety and efficacy of a one gram course of
ferumoxytol, an IV iron treatment currently approved in the United States for
the treatment of IDA in adult chronic kidney disease patients, versus placebo
in adult patients with IDA who had failed or could not tolerate oral iron
treatment, regardless of the underlying cause. This was one of two studies
that formed the foundation for AMAG's supplemental new drug application (sNDA)
in the United States, which was filed in December 2012. AMAG's sNDA seeks to
expand the use of Feraheme® (ferumoxytol) for adult IDA patients who have
failed or could not tolerate oral iron, including those patients with AUB.
The primary efficacy endpoint of this study for U.S. Food and Drug
Administration (FDA) is the proportion of subjects who achieved a > 2.0 g/dL
increase in hemoglobin at any time from baseline to week 5; the primary
efficacy endpoint for European Union (EU) regulators is the mean change in
hemoglobin from baseline to week 5. In the AUB subgroup analysis, 87.3% of
ferumoxytol-treated patients achieved an increase of > 2.0 g/dL in hemoglobin
compared to 3.6% of patients who received placebo, meeting the protocol
defined measure of superiority (p<0.0001). The mean change in hemoglobin in
ferumoxytol-treated AUB patients was 2.8 g/dL, compared to no increase (0.0
g/dL) in AUB patients receiving placebo (p<0.0001). These results paralleled
those in the total study population.
As a pre-defined secondary endpoint in the IDA-301 study, patients were asked
to report on measures of fatigue using the Functional Assessment of Chronic
Illness Therapy (FACIT) instrument. Patients in the AUB subgroup treated with
ferumoxytol demonstrated a 14.0 point improvement in self-reported fatigue
compared to a 7.7 point improvement in those who received placebo (p<0.001).
"Many women with AUB suffer from the symptoms of iron deficiency anemia, such
as serious fatigue, which can have a negative impact on their quality of
life," said Dr. Melvin H. Seid, Director of Clinical Research at Lyndhurst
Gynecologic Associates in Winston Salem, N.C. and a Principal Investigator for
the trial. "Participants in this trial who were treated with ferumoxytol had
significant increases in hemoglobin, which directly correlated to improvements
in self-reported measures of fatigue. AUB patients with iron deficiency anemia
who have not responded well to oral iron supplementation have a need for
additional treatment options. The analysis from this study supports the
potential of ferumoxytol as a new treatment option for patients with IDA from
AUB who have previously had an unsatisfactory response to oral iron therapy."
In the AUB sub-group, the rate of reported adverse events (AEs) was higher
among ferumoxytol-treated patients (47.7%) than in patients that received
placebo (46.4%), although no new safety signals, outside those described in
the current FDA-approved label for ferumoxytol, were observed in this study.
The overall rate of serious adverse events (SAEs) was comparable between the
two treatment groups, with SAEs reported in 1.5% of ferumoxytol-treated
patients, compared to 3.6% of patients that received placebo. Related AEs and
AEs of special interest were higher in ferumoxytol-treated patients in both
the overall population and in patients with AUB. The frequency of reported
events was consistent with the established safety profile of ferumoxytol, as
described in the full prescribing information (see package insert).
Poster No. 85, titled "Evaluation of Ferumoxytol for Treating Iron Deficiency
Anemia from Abnormal Uterine Bleeding" will be presented on Monday, May 6,
from 10:30 a.m. to 5:00 p.m., and poster authors will be available for a
question-and-answer session from 3:00 p.m. to 4:00 p.m.
About Iron Deficiency Anemia
More than 4 million Americans have iron deficiency anemia, of whom
approximately one million are women with dysfunctional or abnormal uterine
bleeding who are treated with a variety of surgical and/or medical management
techniques.^1 The remaining 3 million Americans suffer from anemia due to
other causes; the underlying diseases or conditions causing IDA in these
patients include chronic kidney disease, gastrointestinal disorders,
inflammatory diseases and chemotherapy-induced anemia.Many IDA patients fail
treatment with oral iron due to intolerability, lack of absorption or side
AMAG Pharmaceuticals, Inc. is a specialty pharmaceutical company that
manufactures and markets Feraheme® in the United States. Along with driving
organic growth of its lead product, AMAG intends to expand its portfolio with
additional commercial-stage specialty pharmaceuticals. The company is seeking
complementary products that leverage the company's commercial footprint and
focus on hematology and oncology centers and hospital infusion centers. For
additional company information, please visit www.amagpharma.com.
About Feraheme® (ferumoxytol)/Rienso
In the United States, Feraheme (ferumoxytol) Injection for Intravenous (IV)
use is indicated for the treatment of iron deficiency anemia in adult chronic
kidney disease (CKD) patients. Feraheme received marketing approval from the
U.S. Food and Drug Administration on June 30, 2009 and was commercially
launched by AMAG in the U.S. shortly thereafter.
Ferumoxytol is protected in the U.S. by three issued patents covering the
composition and dosage form of the product. Each issued patent is listed in
the FDA's Orange Book. These patents are set to expire in 2020; a request for
patent term extension has been filed, which, if granted, may extend the patent
term to 2023 for one of the patents.
Ferumoxytol received marketing approval in Canada in December 2011, where it
is marketed by Takeda as Feraheme, and in the European Union in June 2012 and
Switzerland in August 2012, where it is marketed by Takeda as Rienso®.
Feraheme is contraindicated in patients with known hypersensitivity to
Feraheme or any of its components.
Serious hypersensitivity reactions, including anaphylactic-type reactions,
some of which have been life-threatening and fatal, have been reported in
patients receiving Feraheme. Observe patients for signs and symptoms of
hypersensitivity during and after Feraheme administration for at least 30
minutes and until clinically stable following completion of each
administration. Only administer the drug when personnel and therapies are
immediately available for the treatment of anaphylaxis and other
hypersensitivity reactions.Anaphylactic-type reactions, presenting with
cardiac/cardiorespiratory arrest, clinically significant hypotension, syncope,
and unresponsiveness have been reported in the post-marketing experience.In
clinical studies conducted as part of the CKD development program, serious
hypersensitivity reactions were reported in 0.2% (3/1,726) of subjects
receiving Feraheme. Other adverse reactions potentially associated with
hypersensitivity (e.g., pruritus, rash, urticaria or wheezing) were reported
in3.7% (63/1,726) of subjects.
Severe adverse reactions of clinically significant hypotension have been
reported in the post-marketing experience of Feraheme. In clinical studies
conducted as part of the CKD development program, hypotension was reported in
1.9% (33/1,726) of subjects, including three patients with serious hypotensive
reactions. Monitor for signs and symptoms of hypotension following each
Excessive therapy with parenteral iron can lead to excess storage of iron with
the possibility of iatrogenic hemosiderosis. Patients should be regularly
monitored for hematologic response during parenteral iron therapy, noting that
lab assays may overestimate serum iron and transferrin bound iron values in
the 24 hours following administration of Feraheme.
As a superparamagnetic iron oxide, Feraheme may transiently affect magnetic
resonance diagnostic imaging studies for up to 3 months following the last
Feraheme dose. Feraheme will not affect X-ray, CT, PET, SPECT, ultrasound, or
In clinical trials of patients with IDA and CKD, the most commonly occurring
adverse reactions in Feraheme treated patients versus oral iron treated
patients (reported in ≥ 2% of patients) were diarrhea (4.0% vs. 8.2%), nausea
(3.1% vs. 7.5%), dizziness (2.6% vs. 1.8%), hypotension (2.5% vs. 0.4%),
constipation (2.1% vs. 5.7%) and peripheral edema (2.0% vs. 3.2%). In these
trials, adverse reactions leading to treatment discontinuation and occurring
in 2 or more Feraheme treated patients included hypotension, infusion site
swelling, increased serum ferritin level, chest pain, diarrhea, dizziness,
ecchymosis, pruritus, chronic renal failure, and urticaria.
For additional U.S. product information, including full prescribing
information, please visit www.feraheme.com.
This press release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995 and other federal
securities laws. Any statements contained herein which do not describe
historical facts, including but not limited to statements regarding: the
sub-group analysis on patients in IDA-301 with AUB, the expectations and
expected timing for regulatory review of the submission and outcome of the
supplemental new drug application for the broader IDA indication and the
availability of treatment options for patients, and the company's interactions
with the FDA, the patent term extension are forward-looking statements which
involve risks and uncertainties that could cause actual results to differ
materially from those discussed in such forward-looking statements.
Such risks and uncertainties include: (1) uncertainties regarding our and
Takeda's ability to successfully compete in the intravenous iron replacement
market both in the US and outside the US, including the EU, (2) uncertainties
regarding our ability to successfully and timely complete our clinical
development programs and obtain regulatory approval for Feraheme/Rienso in the
broader IDA indication both in the US and outside of the US, including the EU,
(3) the possibility that significant safety or drug interaction problems could
arise with respect to Feraheme/Rienso, (4) uncertainties regarding the
manufacture of Feraheme/Rienso, (5) uncertainties relating to our patents and
proprietary rights, both in the US and outside of the US, (6) the risk of an
Abbreviated New Drug Application (ANDA) filing following the FDA's recently
published draft bioequivalence recommendation for ferumoxytol, and (7) other
risks identified in our Securities and Exchange Commission filings, including
our Quarterly Report on Form 10-Q for the three months ended March 31, 2013
and subsequent filings with the SEC. We caution you not to place undue
reliance on any forward-looking statements, which speak only as of the date
they are made.
We disclaim any obligation to publicly update or revise any such statements to
reflect any change in expectations or in events, conditions or circumstances
on which any such statements may be based, or that may affect the likelihood
that actual results will differ from those set forth in the forward-looking
AMAG Pharmaceuticals and Feraheme are registered trademarks of AMAG
Rienso is a registered trademark of Takeda Pharmaceutical Company Limited.
^(1) Jahn MR, Andreasen HB, Fütterer S, et al. A comparative study of the
physicochemical properties of iron isomaltoside 1000 (Monofer®), a new
intravenous iron preparation and its clinical implications. Eur J Pharm
CONTACT: AMAG Pharmaceuticals, Inc.
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