AMAG Pharmaceuticals reported preliminary results from a Phase 3 study from its global registrational program for Feraheme (ferumoxytol) in patients with iron deficiency anemia (IDA) regardless of the underlying cause.
The IDA-301 study was a double-blind, placebo-controlled trial that randomized patients 3:1 to receive a 1g IV course of Feraheme or placebo, and it was powered to demonstrate superiority on efficacy. The patients enrolled in the study had a history of unsatisfactory response to, or could otherwise not tolerate, oral iron therapy. Patients in this study had IDA associated with various conditions including abnormal uterine bleeding, cancer, gastrointestinal disorders or other causes.
In this study, 608 patients were treated with Feraheme and 200 received placebo, with the demographics and all baseline parameters well balanced between the two treatment groups. The primary efficacy endpoint of the study for US regulators is the proportion of subjects who achieved a ≥2.0g/dL increase in hemoglobin at any time from baseline to Week Five. Patients enrolled in this study were eligible to enter an ongoing extension study, IDA-303, to evaluate repeat dosing with Feraheme; the extension study is fully enrolled with 634 patients.
In the IDA-301 study, Feraheme achieved superiority on both primary efficacy endpoints. Patients treated with Feraheme achieved a statistically significant mean increase in hemoglobin at Week Five of 2.7g/dL, compared to a mean increase of only 0.1g/dL in patients who received placebo. In addition, a ≥2g/dL increase in hemoglobin at any time from baseline to Week Five was achieved in a statistically significantly greater proportion, 81.1%, of patients treated with Feraheme in this study, compared with only 5.5% of patients who received placebo. Further, a statistically significant improvement in fatigue, as assessed by patient reported outcome measures, was demonstrated at Week Five in Feraheme-treated patients.
Feraheme (ferumoxytol) injection for IV use is indicated for the treatment of IDA in adult chronic kidney disease patients.
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