Amag drug found effective in treatment of chronic kidney disease

Patients received either two doses of 510 mg of intravenous (IV) ferumoxytol within one week or 200 mg of oral iron daily for three weeks and were followed for 35 days. The pooled data from 885 dialysis dependent and non-dialysis dependent patients with chronic kidney disease (CKD) demonstrated a statistically significant achievement of the primary endpoint in patients treated with ferumoxytol compared to those treated with oral iron. The primary endpoint was the mean change in hemoglobin from baseline at day 35, and was stratified by age categories of less than 50 years old, 50 to 64 years old, 65 to 74 years old and 75 years and older. The hemoglobin response to IV ferumoxytol consistently increased across all age categories with approximately a 1 g/dl mean hemoglobin increase seen at day 35, and the hemoglobin response was greater with ferumoxytol than with oral iron in each individual age category.

The incidence of adverse events observed in the ferumoxytol group (43.6%) was lower than that observed in the oral iron group (55.7%) across all age categories. Additionally, ferumoxytol-treated patients experienced lower adverse events, serious adverse events and related serious adverse event rates compared to patients receiving oral iron. Moreover, no increase in the rate of adverse events was observed in the ferumoxytol group with increasing age.

Brian Pereira, president and CEO of Amag Pharmaceuticals, said: “We remain on track to file our new drug application for ferumoxytol in CKD patients before the end of 2007.”