of patient enrollment in the second of the company’s two phase III
studies that comprise its global registrational program for Feraheme®
(ferumoxytol) in patients with iron-deficiency anemia (IDA) who are not
candidates for oral iron, regardless of the underlying cause. The two
phase III studies include one comparing treatment with Feraheme to
placebo and one comparing treatment with Feraheme to
treatment with intravenous iron sucrose. Both studies have now completed
enrollment, with more than 1,400 patients enrolled through 210 study
“The completion of enrollment in this program is an important step
forward in AMAG’s goal to expand Feraheme’s reach to a much
larger number of patients who suffer from IDA,” said
Ph.D., executive vice president and chief medical officer of AMAG. “As
we complete data collection and analysis over the next few months, the
results of these studies will form the basis for global regulatory
submissions, which will seek to expand the indication of Feraheme
for the treatment of IDA beyond the current indication for adult
patients with chronic kidney disease.”
AMAG plans to submit a sNDA for the broader U.S. label for Feraheme
regulatory filings seeking the broad IDA indication for Feraheme
in its licensed territories.
manufactures and markets Feraheme® in
company information, please visit www.amagpharma.com.
(IV) use is indicated for the treatment of iron deficiency anemia in
adult chronic kidney disease (CKD) patients. Feraheme received
marketing approval from the
thereafter. For additional product information, please visit www.feraheme.com.
The important safety information below is based on
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
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.
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 30minutes 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.
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 our plans to seek to expand the current indication for
Feraheme and our plans to make the related regulatory filings; the
expected timing of our planned sNDA for Feraheme in the broad IDA
indication to the U.S.
potential opportunity and the number of non-CKD patients with IDA, 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
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 obtain regulatory approval for Feraheme in a
broad IDA indication in the U.S. and in territories outside of the U.S.,
drug interaction problems could arise with respect to Feraheme, (4)
uncertainties regarding our ability to manufacture Feraheme, (5)
uncertainties relating to our patents and proprietary rights, and (6)
other risks identified in our
filings, including our Annual Report on Form 10-K for the year ended
and nine months ended
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.
AMAG Pharmaceuticals, Inc.
Lynn Blenkhorn, 508-851-0930