Trial marks the final clinical milestone on the pathway to pursue a broader Feraheme® label
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.
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
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
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.
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AMAG Pharmaceuticals, Inc.Contact: Linda LennoxVice President, Investor Relations 617-498-2846