AMAG Pharmaceuticals, Inc. today announced that the United States Food and Drug Administration has accepted for review the company’s supplemental new drug application for Feraheme Injection for Intravenous (IV) use, which was submitted to the FDA in December 2012. The sNDA requests FDA approval to expand the indication for ferumoxytol beyond the current indication for the treatment of iron deficiency anemia (IDA) in adult patients with chronic kidney disease (CKD) to adult patients with IDA who have failed or could not take oral iron treatment. Under the Prescription Drug User Fee Act (PDUFA) guidelines, the sNDA is subject to a 10-month review by the FDA. With the acceptance of the submission, the FDA has set October 21, 2013 as a target date for completion of their review.
“Now that our sNDA has been accepted, we look forward to working with the Agency to ensure a timely review of our submission,” said William Heiden, president and chief executive officer of AMAG. “If approved for use in this patient population, Feraheme could provide an important new treatment option for patients suffering from iron deficiency anemia who cannot take or do not respond to oral iron therapy.”
The sNDA submission is based on data from a global phase III program that evaluated the use of ferumoxytol in a broad range of adult IDA patients, all of whom had failed or could not take oral iron treatment. More than 1,400 patients were enrolled in the two phase III clinical trials, known as IDA-301 (placebo comparator) and IDA-302 (active comparator). Both studies achieved their primary efficacy endpoints, with statistically significant improvements in hemoglobin from baseline to the 35-day endpoint of the studies. Adverse events and serious adverse events commonly associated with ferumoxytol and other IV iron therapies, including hypersensitivity reactions, were reported in both studies. No new safety signals, outside of those described in the current Feraheme® (ferumoxytol) label, were observed with ferumoxytol treatment in these studies.
These clinical trials also included patient-reported outcomes data as pre-specified secondary and exploratory endpoints. These outcomes endpoints, including quantitative measures of patients’ fatigue and measures of quality of life, captured the negative impact anemia has on these patients’ lives pre-treatment – and the significant improvement in these scores following a one gram course of therapy with ferumoxytol. These data, and the safety and efficacy data from both IDA-301 and IDA-302 were presented at the 2012 Annual Meeting of the American Society of Hematology.
About Iron Deficiency Anemia
More than 4 million Americans have IDA; 1.6 million of whom are estimated to have CKD, while the other 2.4 million suffer from anemia due to other causes.1 For these patients with anemia due to other causes, the underlying diseases or issues causing IDA 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.2
AMAG Pharmaceuticals, Inc. is a specialty pharmaceutical company that manufactures and markets Feraheme® in the United States. Along with driving organic growth of its lead product, AMAG intends to expand its portfolio with additional commercial-stage specialty pharmaceuticals. The company is seeking complementary products that leverage the company’s commercial footprint and focus on hematology and oncology centers and hospital infusion centers. For additional company information, please visit www.amagpharma.com .
About Feraheme® (ferumoxytol)/Rienso
In the United States, Feraheme (ferumoxytol) Injection for Intravenous (IV) use is indicated for the treatment of iron deficiency anemia in adult chronic kidney disease (CKD) patients. Feraheme received marketing approval from the U.S. Food and Drug Administration on June 30, 2009 and was commercially launched by AMAG in the U.S. shortly thereafter.
Ferumoxytol is protected in the U.S. by three issued patents covering the composition and dosage form of the product. Each issued patent is listed in the FDA’s Orange Book. These patents are set to expire in 2020; a request for patent term extension has been filed, which, if granted, may extend the patent term to 2023 for one of the patents.
Ferumoxytol received marketing approval in Canada in December 2011, where it is marketed by Takeda as Feraheme, and in the European Union in June 2012 and Switzerland in August 2012, where it is marketed by Takeda as Rienso®. For additional U.S. product information, please visit www.feraheme.com .
Feraheme is contraindicated in patients with known hypersensitivity to Feraheme or any of its components.
Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Feraheme. Serious adverse reactions of clinically significant hypotension have been reported. In the post-marketing setting, life-threatening anaphylactic type reactions, cardiac/cardiorespiratory arrest, clinically significant hypotension, syncope, unresponsiveness and other safety events have been reported in patients being treated with Feraheme. In clinical trials, the most commonly occurring adverse reactions for Feraheme-treated patients were nausea, dizziness, hypotension, peripheral edema, headache, edema and vomiting. A full list of adverse events can be found in the full prescribing information for Feraheme.
Source: AMAG