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December 10, 2012
11:22 EDTAMAGAMAG says ferumoxytol met both primary endpoints in two trials
AMAG said in trial IDA-301 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 European Union regulators is the mean change in hemoglobin from baseline to week 5. In the IDA-301 trial, ferumoxytol achieved both primary efficacy endpoints. In IDA-302 the same primary efficacy endpoints were used and in the IDA-302 trial, ferumoxytol achieved both primary efficacy endpoints. 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 label, were observed in this study. In the IDA-302 trial, 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.
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August 31, 2014
14:00 EDTAMAGFBR Capital to hold a conference
Healthcare Conference to be held in Boston on September 3.
13:59 EDTAMAGRW Baird to hold a conference
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