Amag reports positive results from Phase III studies of anemia drug

Patients received either two doses of 510mg of intravenous (IV) ferumoxytol within one week or 200mg of oral iron daily for three weeks and were followed for 35 days. The pooled, post-hoc data demonstrated a statistically significant achievement of the primary endpoint in patients treated with ferumoxytol compared to those treated with oral iron.

For the primary endpoint, the mean change in hemoglobin from baseline at day 35, there was a statistically significant greater mean (plus or minus standard deviation) increase in hemoglobin in patients receiving ferumoxytol compared with patients receiving oral iron (ferumoxytol 1.45 plus or minus 1.27g/dl versus oral iron -0.09 plus or minus 1.47g/dl, p=0.035).

There was also a statistically significantly greater mean increase in hemoglobin from baseline at day 21 in patients receiving ferumoxytol compared with patients receiving oral iron (ferumoxytol 1.04 plus or minus 0.97g/dl versus oral iron 0.23 plus or minus 0.52g/dl; p=0.035). A higher proportion of ferumoxytol-treated patients compared with oral iron-treated patients achieved a 1g/dL or greater rise in hemoglobin at day 21 (47.8% versus 12.5%; p=0.108) and day 35 (60.9% versus 25%; p=0.113).

Brian Pereira, president and CEO of Amag Pharmaceuticals, said: “The treatment of iron deficiency anemia with IV iron has not been extensively studied in kidney transplant recipients. These data are consistent with previously reported ferumoxytol clinical results and suggest that ferumoxytol may also be useful in this patient subgroup.”