AMAG Completes Feraheme® (ferumoxytol) FDA Submission for the Treatment of All Adult Patients With Iron Deficiency Anemia
03 August 2017 - 9:00PM
Filing includes results of head-to-head Phase 3
clinical trial evaluating Feraheme compared to ferric
carboxymaltose injection
Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that it has
completed the submission to the U.S. Food and Drug Administration
(FDA) to broaden the existing label for Feraheme® (ferumoxytol) to
include the treatment of all adults with iron deficiency anemia
(IDA) who have an intolerance or unsatisfactory response to oral
iron. AMAG anticipates an FDA decision on the filing in the first
half of 2018. The current indication of Feraheme is limited to the
treatment of IDA in adults with chronic kidney disease (CKD) who
have failed or cannot tolerate oral iron treatment.
“Approximately 4.5 million Americans have been diagnosed with
IDA and suffer from its debilitating effects.1 This filing brings
us closer to the possibility of offering an alternative intravenous
treatment option to those patients who have failed or are
intolerant to oral iron, including approximately 1.5 million women
with IDA who suffer from gynecological issues, including abnormal
uterine bleeding," said Julie Krop, M.D., chief medical officer and
senior vice president of clinical development and regulatory
affairs at AMAG. “We are very pleased with the recent Phase 3
clinical trial results that are included in the submission, and
would like to thank the many patients and study site participants
who contributed to this important achievement.”
The submission is, in part, supported by positive results from a
previously announced Phase 3 randomized, double-blind,
non-inferiority clinical trial that evaluated Feraheme compared to
Injectafer® (ferric carboxymaltose injection) in approximately
2,000 adults with IDA who had failed or could not tolerate oral
iron or in whom oral iron was contraindicated. The study met its
pre-specified primary endpoint of demonstrating non-inferiority to
Injectafer® based on the primary composite endpoint of the
incidence of moderate-to-severe hypersensitivity reactions
(including anaphylaxis) or moderate-to-severe hypotension.
Additionally, the trial met secondary safety and efficacy
endpoints, including the demonstration of superiority to Injectafer
in efficacy as measured by mean improvement in hemoglobin per gram
of iron administered from baseline to week 5. Importantly, there
were no meaningful differences in the safety profile between the
two agents, with the exception that study results showed a markedly
greater incidence of hypophosphatemia (defined by blood phosphorous
of <0.6 mmol/L from baseline to week 2) in the patients dosed
with Injectafer compared to those in the Feraheme arm of the trial
(Feraheme: 0.4% of patients; Injectafer: 38.7% of patients: rate
difference: -38.3%; 95% confidence interval: -41.46% to
-35.15%).
About Feraheme® (ferumoxytol)Feraheme received
marketing approval from the FDA in June 2009 for the treatment of
IDA in adult CKD patients and was commercially launched by AMAG in
the U.S. shortly thereafter. Ferumoxytol is protected in the U.S.
by seven issued patents covering the composition and dosage form of
the product. Six of the issued patents are listed in the FDA’s
Orange Book, the last of which expires in June 2023.
Fatal and serious hypersensitivity reactions including
anaphylaxis have occurred in patients receiving Feraheme. Initial
symptoms may include hypotension, syncope, unresponsiveness,
cardiac/cardiorespiratory arrest. Feraheme is contraindicated in
patients with a known hypersensitivity to Feraheme or any of its
components, or a history of allergic reaction to any intravenous
iron product.
For additional product information, please see full Prescribing
Information, including Boxed Warning, available at
www.feraheme.com.
About AMAGAMAG is a biopharmaceutical company
focused on developing and delivering important therapeutics,
conducting clinical research in areas of unmet need and creating
education and support programs for the patients and families we
serve. Our currently marketed products support the health of
patients in the areas of maternal and women’s health, anemia
management and cancer supportive care. Through CBR®, we also help
families to preserve newborn stem cells, which are used today in
transplant medicine for certain cancers and blood, immune and
metabolic disorders, and have the potential to play a valuable role
in the ongoing development of regenerative medicine. For additional
company information, please
visit www.amagpharma.com.
Forward-Looking Statements This press release
contains forward-looking information about AMAG
Pharmaceuticals, Inc. 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, among others, AMAG’s beliefs
regarding the study data, AMAG’s belief that the Feraheme filing
brings it closer to the possibility of an alternative
intravenous treatment option to these patients who have failed or
are intolerant to oral iron; AMAG’s expectations to receive
an FDA decision and launch the new indication in the
first half of 2018; and beliefs that newborn stem cells have the
potential to play a valuable role in the development of
regenerative medicine 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, among others, those risks
identified in AMAG’s filings with the U.S. Securities and
Exchange Commission (SEC), including its Annual Report on Form
10-K for the year ended December 31, 2016, its Quarterly
Report on Form 10-Q for the quarter ended March 31, 2017 and
subsequent filings with the SEC. Any such risks and
uncertainties could materially and adversely affect AMAG’s results
of operations, its profitability and its cash flows, which would,
in turn, have a significant and adverse impact on AMAG’s stock
price. AMAG cautions you not to place undue reliance on any
forward-looking statements, which speak only as of the date they
are made.
AMAG disclaims 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® and Feraheme® are registered trademarks of
AMAG Pharmaceuticals, Inc. CBR® is a registered trademark of Cbr
Systems, Inc.
1 Global Intravenous (I.V.) Iron Drugs Market Report: 2015
Edition.
AMAG Pharmaceuticals, Inc. Contacts:
Investors:
Linda Lennox
Vice President, Investor Relations
908-627-3424
Media:
Katie Payne
Vice President, External Affairs
202-669-6786
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