The sNDA submission is based on data from a global phase III program that evaluated the use of ferumoxytol in a broad range of adult IDA patients, all of whom had failed or could not take oral iron treatment. More than 1,400 patients were enrolled in the two phase III clinical trials, known as IDA-301 and IDA-302. Both studies achieved their primary efficacy endpoints, with statistically significant improvements in hemoglobin from baseline to the 35-day endpoint of the studies. Adverse events and serious adverse events commonly associated with ferumoxytol and other IV iron therapies, including hypersensitivity reactions, were reported in both studies. No new safety signals, outside of those described in the current Feraheme label, were observed with ferumoxytol treatment in these studies.
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