AMAG Announces U.S. FDA Filing Acceptance and Six-Month Review of Feraheme® (ferumoxytol) for the Treatment of All Adult Pat...
August 31 2017 - 8:00AM
AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that the
U.S. Food and Drug Administration (FDA) accepted its submission 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. The
FDA has indicated a six-month review timeline and established a
Prescription Drug User Fee Act (PDUFA) target action date of
February 2, 2018. The current indication of Feraheme is limited to
the treatment of IDA in adults with chronic kidney disease (CKD).
“The acceptance of our Feraheme label extension filing marks an
important milestone in our effort to bring Feraheme to the more
than 4.5 million Americans who have been diagnosed with IDA and
suffer from its debilitating effects1," said Julie Krop, M.D.,
chief medical officer and senior vice president of clinical
development and regulatory affairs at AMAG. “A significant
proportion of these patients are women with IDA who suffer from
gynecological issues, including abnormal uterine bleeding. We look
forward to leveraging our deep relationships and expertise in
women's health to bring a potential new treatment option
to this underserved population.”
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. To read
the full press release on these top-line study results please click
here.
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 StatementsThis 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 regarding its’ ability to
leverage its’ deep relationships and expertise in women's health to
bring a potential new treatment option to an underserved
population; 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 quarters ended March 31, 2017 and June
30, 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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