AMAG Pharmaceuticals Announces FDA Acceptance of Supplemental New Drug Application for Feraheme Label Expansion to Include Iron Deficiency Anemia Patients Who Cannot Take Oral Iron
LEXINGTON, Mass.--(BUSINESS WIRE)-- AMAG Pharmaceuticals, Inc. (NAS: AMAG) today announced that the United States Food and Drug Administration (FDA) has accepted for review the company's supplemental new drug application (sNDA) for Feraheme® (ferumoxytol) Injection for Intravenous (IV) use, which was submitted to the FDA in December 2012. The sNDA requests FDA approval to expand the 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 FDA. With the acceptance of the submission, the FDA has set October 21, 2013 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 William Heiden, president and chief executive officer of AMAG. "If approved for 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 American 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
AMAG Pharmaceuticals, Inc. is a specialty pharmaceutical company that manufactures and markets Feraheme® in the United States. Along with 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
In the United States, Feraheme (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 U.S. Food and Drug Administration on June 30, 2009 and 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 Canada in December 2011, where it is marketed by Takeda as Feraheme, and in the European Union in June 2012 and Switzerland in August 2012, where it is marketed by Takeda 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 FDA; the patent term extension; 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 SEC. 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.
AMAG Pharmaceuticals and Feraheme are registered trademarks of AMAG Pharmaceuticals, Inc.
Rienso is a registered trademark of Takeda Pharmaceutical Company Limited.
1 U.S. Census; U.S. Renal Data System, USRDS 2010 Annual Data Report: Atlas of Chronic Kidney Disease and End-Stage Renal Disease in the United States, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 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
KEYWORDS: United States North America Massachusetts
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