Trial marks the final clinical milestone on the pathway to pursue a broader Feraheme® label
WALTHAM, Mass., March 16, 2016 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that it has enrolled the first patient in the 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). This trial is the final study that the company plans to conduct in preparation for filing a 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.
The non-inferiority, randomized, double-blind, multicenter clinical trial will evaluate the incidence of moderate to severe hypersensitivity reactions (including anaphylaxis), and moderate to severe hypotension with Feraheme compared to Injectafer in adults with IDA. Approximately two thousand patients will be randomized in a 1:1 ratio into one of two treatment groups -- Feraheme IV infusion or Injectafer IV infusion. While the trial’s primary endpoint is safety, the study will also assess efficacy.
“Enrolling the first patient in the IDA trial represents an important milestone on our path toward gaining approval to broaden the indication for Feraheme to include all patients with iron deficiency anemia who have failed or are intolerant to oral iron,” said Dr. Julie Krop, chief medical officer and senior vice president of clinical development and regulatory affairs at AMAG. “Approximately 4.5 million Americans have been diagnosed with IDA and suffer from its debilitating effects. These individuals include 1.5 million women under the care of an OB-GYN, including those suffering from abnormal uterine bleeding. We believe additional treatment options are needed to help people living with IDA.”
AMAG expects to file a sNDA upon completion of the clinical trial, with potential approval in late 2018.
“An expanded Feraheme label that includes all adult IDA patients will double the addressable market opportunity for Feraheme and provide for future growth within this broader IDA market segment. Additionally, it provides an opportunity to leverage AMAG’s deep expertise in serving the OB-GYN community, as well as the patients under their care,” said Nik Grund, executive vice president and chief commercial officer at AMAG.
About Feraheme® (ferumoxytol) Injection
Feraheme received marketing approval from the FDA on June 30, 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 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, and 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 the full Prescribing Information, including Boxed Warning, available at www.feraheme.com.
About Iron Deficiency Anemia
Approximately 4.5 million Americans suffer from IDA. For patients with anemia due to causes other than 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.
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.
AMAG is a biopharmaceutical company focused on bringing therapeutics to market that provide clear benefits and help improve people’s lives. Headquartered in Waltham, MA, AMAG possesses a diverse portfolio of products to support the health of patients in the areas of maternal health, anemia management and cancer supportive care. Through CBR®, the company also helps families to preserve newborn stem cells, which are used today in transplant medicine for certain cancers and blood conditions 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 statements within the meaning of the Private Securities Litigation Reform Act of 1995 (PSLRA) and other federal securities laws. Any statements contained herein which do not describe historical facts, including, among others, AMAG’s expectations that no other clinical studies may be needed to receive approval for the broader IDA indication; the timing of the expected filing a supplemental new drug application for such broader IDA indication and the timing of potential approval in 2018; AMAG’s belief that an expanded Feraheme label that includes all adult IDA patients may double the current opportunity for Feraheme and provide for future growth within the broader IDA market; and AMAG’s ability to provide clear benefits and help improve people’s lives, 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, 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 trademark of AMAG Pharmaceuticals, Inc. Cord Blood Registry® and CBR® are registered trademarks of CBR Systems, Inc.
AMAG Pharmaceuticals, Inc. Contact: Linda Lennox Vice President, Investor Relations 617-498-2846
Source:AMAG Pharmaceuticals, Inc.