AMAG Pharmaceuticals announced new data from two pivotal Phase 3 clinical trials that evaluated the use of Feraheme (ferumoxytol) in subjects with iron deficiency anemia (IDA), regardless of the underlying cause of the anemia, who had failed or could not tolerate oral iron treatment. Ferumoxytol consists of a superparamagnetic iron oxide that is coated with a carbohydrate shell.
IDA-301 was a double-blind, placebo-controlled trial designed to compare the safety and efficacy of a one gram IV course of ferumoxytol to IV saline given as placebo. In this study, 608 subjects were treated with ferumoxytol and 200 received placebo. From baseline to Week 5, >80% of study participants treated with ferumoxytol achieved an increase of ≥2g/dL in hemoglobin at any time compared to only 5.5% of subjects who received placebo, meeting the protocol defined measure of superiority (P<0.0001). The mean change in hemoglobin in ferumoxytol-treated subjects was 2.7g/dL, compared to a mean 0.1g/dL increase in subjects receiving placebo (P<0.0001).
IDA-302 was a multicenter, open-label, active-controlled, international clinical trial designed to compare treatment between ferumoxytol and iron sucrose. Subjects were randomized 2:1 to receive a one gram IV course of either ferumoxytol (n=406) or iron sucrose (n=199). Subjects treated with ferumoxytol achieved a significantly greater mean increase in hemoglobin of 2.7g/dL at Week 5, compared to a 2.4g/dL increase for those treated with iron sucrose (P<0.013). By Week 5, 84% of ferumoxytol-treated subjects achieved a ≥2g/dL increase in hemoglobin, compared to 81% of those treated with iron sucrose.
Feraheme is indicated for the treatment of IDA in adult chronic kidney disease (CKD) patients.
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