the company’s supplemental new drug application (sNDA) for Feraheme®
(ferumoxytol) Injection for Intravenous (IV) use, which was submitted to
indication for ferumoxytol beyond the current indication for the
treatment of iron deficiency anemia (IDA) in adult patients with chronic
kidney disease (CKD) to adult patients with IDA who have failed or could
not take oral iron treatment. Under the Prescription Drug User Fee Act
(PDUFA) guidelines, the sNDA is subject to a 10-month review by the
With the acceptance of the submission, the
as a target date for completion of their review.
“Now that our sNDA has been accepted, we look forward to working with
the Agency to ensure a timely review of our submission,” said
use in this patient population, Feraheme could provide an important new
treatment option for patients suffering from iron deficiency anemia who
cannot take or do not respond to oral iron therapy.”
The sNDA submission is based on data from a global phase III program
that evaluated the use of ferumoxytol in a broad range of adult IDA
patients, all of whom had failed or could not take oral iron treatment.
More than 1,400 patients were enrolled in the two phase III clinical
trials, known as IDA-301 (placebo comparator) and IDA-302 (active
comparator). Both studies achieved their primary efficacy endpoints,
with statistically significant improvements in hemoglobin from baseline
to the 35-day endpoint of the studies. Adverse events and serious
adverse events commonly associated with ferumoxytol and other IV iron
therapies, including hypersensitivity reactions, were reported in both
studies. No new safety signals, outside of those described in the
current Feraheme® (ferumoxytol) label, were observed with ferumoxytol
treatment in these studies.
These clinical trials also included patient-reported outcomes data as
pre-specified secondary and exploratory endpoints. These outcomes
endpoints, including quantitative measures of patients’ fatigue and
measures of quality of life, captured the negative impact anemia has on
these patients’ lives pre-treatment – and the significant improvement in
these scores following a one gram course of therapy with ferumoxytol.
These data, and the safety and efficacy data from both IDA-301 and
IDA-302 were presented at the 2012 Annual Meeting of the
Society of Hematology
About Iron Deficiency Anemia
More than 4 million Americans have IDA; 1.6 million of whom are
estimated to have CKD, while the other 2.4 million suffer from anemia
due to other causes.1 For these patients with anemia due to
other causes, the underlying diseases or issues causing IDA include
abnormal uterine bleeding, gastrointestinal disorders, inflammatory
diseases and chemotherapy-induced anemia. Many IDA patients fail
treatment with oral iron due to intolerability or side effects.2
manufactures and markets Feraheme® in
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
(IV) use is indicated for the treatment of iron deficiency anemia in
adult chronic kidney disease (CKD) patients. Feraheme received marketing
approval from the
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
where it is marketed by Takeda as Feraheme, and in the
as Rienso®. For additional U.S. product information, please visit www.feraheme.com.
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. Serious adverse reactions of
clinically significant hypotension have been reported. In the
post-marketing setting, life-threatening anaphylactic type reactions,
cardiac/cardiorespiratory arrest, clinically significant hypotension,
syncope, unresponsiveness and other safety events have been reported in
patients being treated with Feraheme. In clinical trials, the most
commonly occurring adverse reactions for Feraheme-treated patients were
nausea, dizziness, hypotension, peripheral edema, headache, edema and
vomiting. A full list of adverse events can be found in the full
prescribing information for 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: the 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; the
company’s interactions with the
company’s intentions and beliefs regarding the FDA’s recently published
draft bioequivalence recommendation for ferumoxytol; the company’s
intent to drive organic growth of Feraheme; and the company’s
plans to seek complementary commercial products to add to its portfolio
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 Annual Report on Form 10-K for the year ended December 31, 2012 and
subsequent filings with the
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.
Rienso is a registered trademark of
1 U.S. Census; U.S. Renal Data System, USRDS 2010 Annual
Data Report: Atlas of Chronic Kidney Disease and End-Stage Renal Disease
Institute of Diabetes and Digestive
2010: 41-42; Fishbane, S. et al. Iron Indices in CKD in the NHANES
1998-2004. Clin J Am Soc Nephrol. 2009 January; 4(1): 57–61.
2 Barton, James et al. Intravenous iron dextran therapy in
patients with iron deficiency and normal renal function who failed to
respond to or did not tolerate oral iron supplementation. Am J
Medicine. 2000; 109: 27-32.
AMAG Pharmaceuticals, Inc.
Amy Sullivan, 617-498-3303