In IDA-301, the overall rate of reported adverse events was higher in the ferumoxytol group than in the placebo group, although no new safety signals, outside of those described in the current Feraheme® (ferumoxytol) label, were observed in this study. The overall rate of serious adverse events (SAEs) was comparable between the two treatment groups, and two related SAEs of hypersensitivity, including one anaphylactic reaction, were reported in ferumoxytol-treated patients.
The patient-reported outcomes data are being presented in an oral presentation today at the ASH annual meeting. The safety and efficacy data from IDA-301 were presented in a poster session on Sunday, December 9, 2012 at the ASH annual meeting.
IDA-302 Study and Results
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), and the demographics and all baseline parameters were well balanced between the two treatment groups. The primary efficacy endpoint for U.S. regulators 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 E.U. regulators is the mean change in hemoglobin from baseline to week 5.In the IDA-302 trial, ferumoxytol achieved both primary efficacy endpoints. Subjects treated with ferumoxytol achieved a significantly greater mean increase in hemoglobin of 2.7 g/dL at week 5, compared to a 2.4 g/dL increase for those treated with iron sucrose (p<0.013). By week 5, 84% of ferumoxytol-treated subjects achieved a ≥ 2.0 g/dL increase in hemoglobin, compared to 81% of those treated with iron sucrose. The overall rates of adverse events and related adverse events were comparable in ferumoxytol- and iron sucrose-treated subjects, and included many attributable to comorbid disease. However, the overall rate of SAEs, both related and unrelated as assessed by the investigator, was higher in ferumoxytol-treated subjects. The SAEs in two ferumoxytol-treated subjects were reported as related to the study drug by the investigators; these included one anaphylactoid reaction and one case of hypertension. In this study, no new safety signals, outside of those described in the current Feraheme® (ferumoxytol) label, were identified.