Data Shows Patients Treated with Feraheme® (ferumoxytol) were Less Likely to Develop Severe
Hypophosphatemia Compared to Those Treated with a Comparator IV Iron
WALTHAM, Mass., Nov. 06, 2017 (GLOBE NEWSWIRE) — AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced data related to the occurrence of hypophosphatemia following intravenous (IV) iron treatment at a podium presentation at the 2017 American Society of Nephrology (ASN) annual meeting in New Orleans. The impact of the use of IV iron on phosphate metabolism was assessed as a secondary exploratory endpoint of the Phase 3 randomized, double-blind, non-inferiority clinical trial of Feraheme® (ferumoxytol) and Injectafer® (ferric carboxymaltose injection). This study was comprised of approximately 2,000 adult patients with iron deficiency anemia regardless of the cause who had failed or could not tolerate oral iron therapy. The data demonstrated that patients treated with Feraheme were markedly less likely to develop severe hypophosphatemia compared to those treated with Injectafer®.
“The data showed that severe hypophosphatemia occurred in 38.7 percent of patients on ferric carboxymaltose injection compared to 0.4 percent of patients treated with ferumoxytol,” said Dr. Myles Wolf, MD, Chief of the Division of Nephrology at Duke University School of Medicine. “Understanding that few of the patients treated with ferumoxytol developed severe hypophosphatemia may be important for prescribing physicians.”
In the Phase 3 trial, of the 997 patients treated with Feraheme, severe hypophosphatemia occurred in 4 people compared to 397 out of 1,000 people treated with Injectafer®. Among patients receiving standard courses of Injectafer® (750mg x 2 doses), mean blood phosphorus levels decreased [from baseline] at all time points (day 8, week 2 and week 5) compared to Feraheme (510 mg x 2 doses). Severe hypophosphatemia is defined as a serum phosphate level of less than 2.0 mg/dL (0.6 mmol/L).
“Phosphate is required for a broad array of cellular processes and provides mineral strength to bone,” said Julie Krop, M.D., chief medical officer and senior vice president of clinical development and regulatory affairs at AMAG. “AMAG felt it was important to evaluate serum phosphate in this large clinical trial as case reports of hypophosphatemia associated with important long term consequences such as bone pain, weakness, and osteomalacia have been on the rise and require further clinical investigation.”
About The Phase 3 Trial
AMAG Pharmaceuticals, Inc. previously announced positive top-line results from the Phase 3 randomized, double-blind, non-inferiority clinical trial. The trial evaluated Feraheme (ferumoxytol) compared to Injectafer® (ferric carboxymaltose injection) in approximately 2,000 adults with iron deficiency anemia (IDA) regardless of the cause who had failed or could not tolerate oral iron therapy. The current indication of Feraheme is limited to the treatment of IDA in adults with chronic kidney disease (CKD).
The study results demonstrated non-inferiority to Injectafer® based on the primary composite endpoint of incidence of moderate-to-severe hypersensitivity reactions (including anaphylaxis) and moderate-to-severe hypotension. Additionally, the trial met secondary safety and efficacy endpoints, including the demonstration of superiority to Injectafer® in mean improvement in hemoglobin per gram of iron administered from baseline to week 5. To read the full press release on these top-line trial results please click here.
Based, in part, upon these trial results, AMAG completed the submission to the FDA to broaden the current label of Feraheme to include the treatment of all adults with IDA regardless of cause who had failed or could not tolerate oral iron therapy, and has received a PDUFA date of February 2, 2018.
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.
AMAG 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.
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 beliefs regarding the study data and how important the incidence of severe hypophosphatemia may be to prescribing physicians; AMAG’s beliefs about the importance of serum phosphate and the long term consequences associated with hypophosphatemia, such as bone pain, weakness, asthenia, and osteomalacia; 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, June 30, 2017 and September 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.
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