The planned safety trial follows the Complete Response Letter (CRL) AMAG received from the
“We have worked closely with the
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
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 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.
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
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.
AMAG Pharmaceuticals, Inc. Linda Lennox, 617-498-2846 Vice President, Investor Relations & Corporate Communications