Key Findings of a 6-Month Extension Study Presented at the American Society of Hematology Annual Meeting
WALTHAM, Mass., Dec. 03, 2018 (GLOBE NEWSWIRE) — AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that research supported by the Company, “Sustained Improvements in Fatigue and Quality of Life in Iron Deficiency Anemia Patients Following a Single Course of Ferumoxytol: Results of a 6-Month Extension Study,” was presented as a poster presentation on Saturday, December 1, 2018, at the American Society of Hematology (ASH) annual meeting in San Diego.
The ASH poster presentation focused on the durability of the improvements in several patient reported outcomes (PRO) measures in patients with iron deficiency anemia (IDA) following a single course of ferumoxytol (2 x 510 mg, 3-8 days apart) over a 6-month extension study period. In the initial phase 3 trial, patients treated with ferumoxytol showed improvement in quality of life compared to placebo as measured by fatigue-related symptoms. In terms of the durability of response, the extension study found that 61 percent of patients treated with ferumoxytol in the primary study never needed re-treatment during the 6-month period of the extension study, as measured by pre-specified criteria. Ferumoxytol is the sole IV iron therapy that has demonstrated an improvement in fatigue-related quality of life PRO scores in a double-blind placebo controlled trial.
“An estimated 5 million adults in the United States suffer from the debilitating effects of IDA1, many of whom are also facing other challenging conditions such as cancer2, chronic kidney disease3, and abnormal uterine bleeding4,” said Brian Robinson, M.D., senior vice president, medical affairs, at AMAG. “This new research suggests that treatment with ferumoxytol can offer these patients sustained, meaningful improvements in their energy levels and, therefore, their quality of life.”
The Phase 3 double-blind, placebo-controlled trial had previously found that patients with IDA who had failed or could not tolerate oral iron had very poor baseline health-related quality of life (HRQOL) scores associated with fatigue, and that IV iron treatment with ferumoxytol resulted in clinically meaningful improvements over a 5-week study period. Patients were subsequently evaluated for IDA on a monthly basis throughout the 6-month extension study and those with persistent or recurrent IDA (Hgb <11.0 g/dL and TSAT <20%) received an additional course of ferumoxytol. The majority of patients enrolled in the extension study who had received ferumoxytol in the double-blind trial (285/471; 61%) did not need to receive any further doses of ferumoxytol as their mean Hgb had increased from 9.0±0.8 g/dL at Baseline to 12.1±1.1 at Week 5 of the double-blind trial and remained above 12.0 throughout the 6-month extension study (Month 7 Hgb 12.1±1.2). The subgroup of patients who did not receive any additional doses of ferumoxytol reported reductions in fatigue, increases in energy, vitality, and ability to perform activities of daily living (ADL) and improvements in HRQOL that were sustained over the 6-month period. The same validated PRO instruments were administered in this extension study as in the preceding double-blind trial: Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-Fatigue), Short Form Health Survey (SF-36), Linear Analogue Scale Assessment (LASA) of Energy, ADL and HRQOL.
About Feraheme® (ferumoxytol injection)
Feraheme received initial 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. In February 2018, Feraheme received additional approval for expanded label to treat all eligible adult IDA patients who have intolerance to oral iron or have had unsatisfactory response to oral iron in addition to patients who have CKD. 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. Hypersensitivity reactions have occurred in patients in whom a previous Feraheme dose was tolerated. Patients with a history of multiple drug allergies may have a greater risk of anaphylaxis with parenteral iron products. Feraheme is contraindicated in patients with known hypersensitivity to Feraheme or any of its components, or a history of allergic reaction to any intravenous iron product. Feraheme may cause clinically significant hypotension. Excessive therapy with parenteral iron can lead to excess storage of iron and possible hemosiderosis. Administration of Feraheme may transiently affect the diagnostic ability of magnetic resonance imaging. The most common adverse reactions (≥ 2%) are diarrhea, headache, nausea, dizziness, hypotension, constipation, and peripheral edema.
For additional product information, please see full Prescribing Information, including Boxed Warning, available at www.feraheme.com.
About AMAG
AMAG is a pharmaceutical company focused on bringing innovative products to patients with unmet medical needs. The company does this by leveraging its development and commercial expertise to invest in and grow its pharmaceutical products across a range of therapeutic areas, including women’s health. 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 belief that its research indicates that treatment with ferumoxytol can offer certain patients sustained, meaningful improvements in their energy levels and, therefore, their quality of life 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, 2017, its Quarterly Reports on Form 10-Q for the quarters ending June 30, 2018 and September 30, 2018 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.
AMAG Pharmaceuticals, Inc. Contacts:
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1Miller JL. Iron deficiency anemia: a common and curable disease. Cold Spring Harb Perspect Med. 2013;3(7):1-13.
2 Naoum FA. Iron deficiency anemia in cancer patients. Rev Bras Hematol Hemoter. 2016;38(4):325-330.
3 National Center for Chronic Disease Prevention and Health Promotion, Division of Diabetes Translation. National chronic kidney disease fact sheet, 2017. Published June 7, 2017. Accessed April 23, 2018.
4 Morrison J, et al. Assessment of the prevalence and impact of anemia on women hospitalized for gynecologic conditions associated with heavy uterine bleeding. J Reproductive Med 2008;53 :323-330.