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Preliminary Results Reported From Phase III Study of Feraheme in Patients With Iron Deficiency Anemia
The study, IDA-301, compared Feraheme with placebo in a total of 808 patients with IDA. All of the patients had a history of an unsatisfactory response to oral iron therapy or were intolerant of such therapy. The patients’ IDA was associated with various conditions, including abnormal uterine bleeding, cancer, and gastrointestinal disorders.
The IDA-301 study was a double-blind, placebo-controlled trial that randomly assigned patients to receive a 1-gram intravenous course of Feraheme (n = 608) or placebo (n = 200). The primary efficacy endpoint of the study was the proportion of patients that achieved a 2.0-g/dL increase in hemoglobin at any time from baseline to week 5. Of the patients in this study, 634 entered an ongoing extension phase to evaluate repeat dosing with Feraheme.
In the IDA-301 study, patients treated with Feraheme showed a statistically significant mean increase in hemoglobin of 2.7 g/dL at week 5, compared with a mean increase of 0.1 g/dL in the placebo group. In addition, a 2.0-g/dL increase in hemoglobin at any time from baseline to week 5 was achieved by 81.1%, of Feraheme-treated patients compared with 5.5% of placebo-treated patients.
Feraheme Injection for Intravenous Use was approved by the FDA in June 2009 for the treatment of iron deficiency anemia in adults with chronic kidney disease. With the results of the new phase III study, AMAG Pharmaceuticals plans to seek additional approval for the treatment of a broader population of patients with iron deficiency anemia and a history of an unsatisfactory response to oral iron therapy.
The company expects to submit a supplemental new drug application for the broader IDA indication by the end of 2012.
For more information, visit AMAG Pharmaceuticals.