Study Meets Primary Efficacy Endpoints
results from the first of two phase III studies that comprise its global
registrational program for Feraheme® (ferumoxytol) in patients
with iron-deficiency anemia (IDA) regardless of the underlying cause.
The study being reported today compared treatment with Feraheme to
treatment with intravenous (IV) iron sucrose, and enrolled 605 patients
at 74 sites in
in the study had a history of unsatisfactory oral iron therapy, and had
IDA associated with various conditions including abnormal uterine
bleeding, cancer, gastrointestinal disorders or other causes.
The study was an open-label, active-controlled trial that randomized
patients 2:1 to receive a one gram IV course of either Feraheme
(n=406) or iron sucrose (n=199), and it was powered to demonstrate
non-inferiority on efficacy. The demographics and all baseline
parameters were well balanced between the two treatment groups. The
primary efficacy endpoint of the study was the mean change in hemoglobin
from baseline to week five or the proportion of subjects who achieved a
≥ 2.0 g/dL increase in hemoglobin at any time from baseline to week
five, depending on the regulatory authority.
In this study, Feraheme achieved the predefined criteria for
non-inferiority on both primary efficacy endpoints. Patients treated
with Feraheme achieved a mean increase in hemoglobin at week five
of 2.7 g/dL, compared to a mean increase of 2.4 g/dL in patients treated
with IV iron sucrose. A ≥ 2.0 g/dL increase in hemoglobin at any time
from baseline to week five was achieved in 84% of patients treated with Feraheme,
compared with 81% of patients treated with IV iron sucrose.
No new safety signals were observed with Feraheme and the types
of reported adverse events were consistent with those seen in previous
studies and those contained in the U.S. package insert for Feraheme.
Overall adverse events (AEs) were comparable between the treatment arms,
with AEs reported in 41.4% of Feraheme-treated patients, compared
to 44.2% of patients treated with IV iron sucrose.
Patients in both treatment groups experienced protocol-defined adverse
events of special interest, which included moderate to severe
hypotension or hypersensitivity reactions, ranging from fever alone to
an anaphylactoid reaction. Cardiovascular AEs were comparable between
the two treatment groups. Serious adverse events (SAEs) were reported in
4.2% of Feraheme-treated patients, compared to 2.5% of patients
treated with IV iron sucrose; the SAEs reported in two Feraheme treated
patients (0.5%) were reported as related by the investigators.
“We are pleased that Feraheme met the primary efficacy endpoint
in each of the planned analyses of this study, and that no new safety
signals were identified with Feraheme. Importantly, Feraheme
treatment resulted in robust, clinically relevant increases in
hemoglobin in this broad patient population with a high unmet medical
need,” said
global registrational program for Feraheme consists of two phase
III studies, the second of which will read out in the coming months. We
are currently starting to prepare for the submission of a supplemental
new drug application to the
approval for Feraheme to treat this broader population of
patients with iron deficiency anemia and a history of unsatisfactory
oral iron therapy.”
The other study in the registrational program, being conducted in the
US,
placebo in 800 patients. This study is now fully enrolled with results
expected in mid-2012. AMAG plans to submit an sNDA for the broader U.S.
iron deficiency anemia label for Feraheme to the
Drug Administration
About
is a biopharmaceutical company that manufactures and markets Feraheme®
in
About Feraheme
In
(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
launched by AMAG in the U.S. shortly thereafter. Feraheme received
marketing approval in
review by the
information, please visit www.feraheme.com.
Forward Looking Statements
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: the preliminary nature of the data being
reported in this press release, the fact that no new Feraheme safety
signals were identified, the expected timing of the read out and results
of our second Phase II clinical trial of Feraheme in the
broader IDA patient population, and our plan to prepare and the expected
timing of our sNDA filing in the U.S. for Feraheme for the
broad iron deficiency anemia indication, 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 U.S. and outside the U.S., (2)
uncertainties regarding our ability to successfully and timely complete
our clinical development programs and obtain regulatory approval for Feraheme in
the broader IDA indication both in the U.S. and in territories outside
of the U.S., including the European Union, (3) the fact that significant
safety or drug interaction problems could arise with respect to Feraheme,
(4) the risk that final data from the clinical trial described herein
could differ materially from or be subject to differing interpretations
by regulatory authorities than set forth in this press release, (5)
uncertainties regarding our ability to manufacture Feraheme,
(6) uncertainties relating to our patents and proprietary rights, and
(7) other risks identified in our Securities and Exchange
Commission filings, including our Annual Report on Form 10-K for the
years ended December 31, 2010 and 2011 and our Quarterly Report on Form
10-Q for the three and nine months ended September 30, 2011. 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 statements.
The important safety information below is based on
prescribing information.
Important Safety Information About Feraheme
Indication and contraindications
Feraheme is indicated for
the treatment of iron deficiency anemia in adult patients with chronic
kidney disease. Feraheme is contraindicated in patients with known
hypersensitivity to Feraheme or any of its components.
Warnings and precautions
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, 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 in 3.7% (63/1,726) of subjects.
Severe adverse reactions of clinically significant hypotension have
been reported in the post-marketing experience. In clinical studies,
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 Feraheme injection. 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 nuclear imaging.
Adverse reactions
In clinical trials, the most commonly
occurring adverse reactions in Feraheme treated patients versus oral
iron treated patients reported in ≥ 2% of chronic kidney disease
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 clinical
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.
Post-marketing safety experience
The following adverse
reactions have been identified during post-approval use of Feraheme.
Because these reactions are reported voluntarily from a population of
uncertain size, it is not always possible to reliably estimate their
frequency or establish a causal relationship to drug exposure.
The following serious adverse reactions have been reported from the
post-marketing spontaneous reports with Feraheme: life-threatening
anaphylactic-type reactions, cardiac/cardiorespiratory arrest,
clinically significant hypotension, syncope, unresponsiveness, loss of
consciousness, tachycardia/rhythm abnormalities, angioedema, ischemic
myocardial events, congestive heart failure, pulse absent, and cyanosis.
These adverse reactions have occurred up to 30 minutes after the
administration of Feraheme injection. Reactions have occurred following
the first dose or subsequent doses of Feraheme.
For full prescribing information, please visit www.feraheme.com.
Source:
AMAG Pharmaceuticals, Inc.
Amy Sullivan, 617-498-3303
