WALTHAM, Mass., Oct. 28, 2015 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that it has commenced start-up activities for its head-to-head Phase 3 clinical trial evaluating the safety of Feraheme® (ferumoxytol) compared to Injectafer® (ferric carboxymaltose injection) in adults with iron deficiency anemia (IDA).
The planned safety trial follows the Complete Response Letter (CRL) AMAG received from the U.S. Food and Drug Administration (FDA) in January 2014 regarding its supplemental new drug application (sNDA) to broaden the use of Feraheme beyond the current chronic kidney disease (CKD) indication to include all adult IDA patients who have failed or cannot tolerate oral iron treatment.
"We have worked closely with the FDA to develop a path forward for potentially broadening the indication for Feraheme to include all patients with iron deficiency anemia. This safety trial represents a significant step forward in that process," said Dr. Julie Krop, chief medical officer and senior vice president of clinical development and regulatory affairs at AMAG. "Approximately 4.5 million Americans suffer from the debilitating effects of IDA, and we believe healthcare providers need additional treatment options to help care for their IDA patients."
The randomized, double-blind, multicenter non-inferiority trial will evaluate the incidence of moderate to severe hypersensitivity reactions (including anaphylaxis), and moderate to severe hypotension with Feraheme compared to ferric carboxymaltose injection in adults with IDA. Two thousand patients will be randomized in a 1:1 ratio into one of two treatment groups – 1.02 grams of Feraheme intravenous (IV) infusion or 1.5 grams of ferric carboxymaltose injection. While the trial's primary endpoint is safety, the study will also assess efficacy.
"Moving forward with this head-to-head clinical trial to support potential FDA regulatory approval for a broader indication of Feraheme highlights our commitment to not only the IDA community but also to maternal health," said William Heiden, chief executive officer of AMAG. "Today, 1.5 million of the 4.5 million Americans already diagnosed with IDA are women with abnormal uterine bleeding, or who are pregnant or post-partum. Many of these women are under the care of the obstetricians who are called upon by our maternal health commercial team. We believe an expanded indication would allow us to help these women, as well as other patients whose IDA has not been successfully treated with oral iron."
AMAG expects to begin enrolling patients in the trial in the first quarter of 2016, with a potential sNDA approval and launch in 2018.
About AMAG
AMAG Pharmaceuticals uses its business and clinical expertise to develop and commercialize therapeutics that provide clear benefits and improve people's lives. Based in Waltham, Mass., AMAG has a diverse portfolio of products in the areas of maternal health, anemia management and cancer supportive care. AMAG continues to work to expand the impact of these and future products for patients by delivering on its aggressive growth strategy, which includes organic growth, as well as the pursuit of products and companies that align with AMAG's existing therapeutic areas or those that could benefit from its proven core competencies. For additional company information, please visit www.amagpharma.com.
About Feraheme® (ferumoxytol) Injection
Feraheme received marketing approval from the FDA on June 30, 2009 for the treatment of iron deficiency anemia (IDA) in adult chronic kidney disease (CKD) patients and was commercially launched by AMAG in the U.S. shortly thereafter. Ferumoxytol is protected in the U.S. by six issued patents covering the composition and dosage form of the product. Each issued patent is 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 U.S. product information, please see full Prescribing Information, including Boxed Warning, available at www.feraheme.com.
About Iron Deficiency Anemia
Approximately 4.5 million Americans suffer from iron deficiency anemia (IDA). For patients with anemia due to causes other than chronic kidney disease (CKD), underlying conditions 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.1
In 2014, an estimated 650,000 patients were treated with IV iron outside the dialysis setting, approximately half of whom were estimated to have CKD, with the other half suffering from IDA caused by conditions other than CKD.
Forward-looking Statements
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, among others, statements regarding the parameters and time-lines for the conduct of the IDA clinical trial; the potential approval of the sNDA to broaden the use of Feraheme to include all adult IDA patients who have failed or cannot tolerate oral iron treatment, including the anticipated timing for such approval and launch; the size of the market opportunity for Feraheme if such expanded label is approved, the potential benefit to patients of Feraheme if the sNDA is approved and anticipated future growth in sales of Feraheme; 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, 2014, its Quarterly Report on Form 10-Q for the quarter ended June 30, 2015, 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. Source: AMAG Pharmaceuticals, Inc.
1 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.