8:30AM AMAG Pharma: Ferumoxytol results in significant hemoglobin increases in Adult Iron deficiency anemia patients with abnormal uterine bleeding who had failed or could not tolerate oral iron therapy (AMAG) 23.37 : Co 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 annual meeting in New Orleans, Louisiana. In the full IDA-301 study, 608 adult patients with iron deficiency anemia 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.
The primary efficacy endpoint of this study for 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.
In the AUB sub-group, the rate of reported adverse events (AEs) was higher among ferumoxytol-treated patients (47.7%) than in patients that received placebo (46.4%), although no new safety signals, outside those described in the current FDA-approved label for ferumoxytol, were observed in this study.
