LEXINGTON, Mass., May 6, 2013 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (Nasdaq:AMAG) today announced that a new sub-group analysis from IDA-301, a phase III, randomized, placebo-controlled clinical trial, will be presented today at the first poster session of the American College of Obstetrics and Gynecology (ACOG) annual meeting in New Orleans, Louisiana. In the full IDA-301 study, 608 adult patients with iron deficiency anemia (IDA) who had failed or could not tolerate oral iron were treated with ferumoxytol and 200 received placebo, with the demographics and all baseline parameters well balanced between the two treatment groups. The sub-group analysis being presented today at ACOG is based on 344 patients in IDA-301 with abnormal uterine bleeding (AUB), the most frequent underlying cause for IDA in this study, with 260 AUB patients randomized to ferumoxytol and 84 to placebo.
IDA-301 was a randomized, double-blind, placebo-controlled multicenter trial designed to compare the safety and efficacy of a one gram course of ferumoxytol, an IV iron treatment currently approved in the United States for the treatment of IDA in adult chronic kidney disease patients, versus placebo in adult patients with IDA who had failed or could not tolerate oral iron treatment, regardless of the underlying cause. This was one of two studies that formed the foundation for AMAG's supplemental new drug application (sNDA) in the United States, which was filed in December 2012. AMAG's sNDA seeks to expand the use of Feraheme® (ferumoxytol) for adult IDA patients who have failed or could not tolerate oral iron, including those patients with AUB.
The primary efficacy endpoint of this study for U.S. Food and Drug Administration (FDA) is the proportion of subjects who achieved a > 2.0 g/dL increase in hemoglobin at any time from baseline to week 5; the primary efficacy endpoint for European Union (EU) regulators is the mean change in hemoglobin from baseline to week 5. In the AUB subgroup analysis, 87.3% of ferumoxytol-treated patients achieved an increase of > 2.0 g/dL in hemoglobin compared to 3.6% of patients who received placebo, meeting the protocol defined measure of superiority (p<0.0001). The mean change in hemoglobin in ferumoxytol-treated AUB patients was 2.8 g/dL, compared to no increase (0.0 g/dL) in AUB patients receiving placebo (p<0.0001). These results paralleled those in the total study population.As a pre-defined secondary endpoint in the IDA-301 study, patients were asked to report on measures of fatigue using the Functional Assessment of Chronic Illness Therapy (FACIT) instrument. Patients in the AUB subgroup treated with ferumoxytol demonstrated a 14.0 point improvement in self-reported fatigue compared to a 7.7 point improvement in those who received placebo (p<0.001).