AMAG Pharmaceuticals announced positive preliminary data from the IDA-303 study that evaluated the safety and efficacy of repeat dosing with ferumoxytol in patients with persistent or recurring iron deficiency anemia (IDA), regardless of the underlying cause and a history of unsatisfactory oral iron therapy or in whom oral iron could not be used.
IDA-303 is a single-arm, open-label extension study that enrolled 624 patients who had completed treatment in IDA-301, a randomized, double-blind, placebo-controlled trial in which patients received either one gram intravenous course of ferumoxytol or placebo.
During the course of the IDA-303 study, 337 patients were treated with ferumoxytol of whom 151 had received placebo in IDA-301. Therefore these patients received their first course of ferumoxytol in the IDA-303 study. A total of 244 patients received a second course of ferumoxytol, of whom 186 patients had received their first course in IDA-301. The remainder of patients enrolled in IDA-303 did not receive treatment, suggesting the durability of response to the first course of ferumoxytol administered in the IDA-301 study. The primary efficacy endpoint of IDA-303 was the mean change in hemoglobin from baseline to week five following the first course of ferumoxytol.
Results demonstrated that the 151 patients who received their first course of therapy in IDA-303 achieved a statistically significant mean increase in hemoglobin from baseline to week five of 2.6g/dL. This change was consistent with the 2.7g/dL increase in hemoglobin reported for ferumoxytol-treated patients in both the IDA-301 and IDA-302 studies.
Feraheme (ferumoxytol) injection for IV use is already indicated for the treatment of IDA in adult chronic kidney disease patients.
For more information call (617) 498-3300 or visit www.amagpharma.com.