AMAG Pharmaceuticals Inc (AMAG) Wednesday announced positive preliminary results from the second phase III study for Feraheme in patients with iron deficiency anemia or IDA, regardless of the underlying cause.
The biopharmaceutical company stated that the study, called as IDA-301, compared Feraheme treatment to placebo and enrolled patients having IDA associated with various conditions including abnormal uterine bleeding, cancer, gastrointestinal disorders or other causes.
The company further stated that Feraheme demonstrated superiority on all primary efficacy endpoints evaluated in this study.
The company added that the efficacy and safety of Feraheme in this study were comparable to that reported in the IDA-302 study, the phase III IDA study comparing Feraheme to iron sucrose.
In the IDA-301 study, Feraheme demonstrated robust efficacy, achieving superiority on both primary efficacy endpoints. Patients treated with Feraheme achieved a statistically significant mean increase in hemoglobin at week five of 2.7 g/dL, compared to a mean increase of only 0.1 g/dL in patients who received placebo; importantly, these data are consistent with the 2.7 g/dL increase in hemoglobin reported in the IDA-302 study,
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