Chronic Renal Anemia
February 4, 2008
AMAG issued positive results from three phase III trials of ferumoxytol as an intravenous treatment of iron deficiency anemia in patients with chronic kidney disease (CKD). These results addressed mortality rates and adverse events and were consistent with previously reported phase III results. The open-label, multi-center, randomized trials enrolled a total of two thousand and seventy four non-dialysis and dialysis-dependent subjects with CKD. The subjects received either intravenous ferumoxytol or oral iron. Overall, thirty-one deaths occurred, none of which were considered to be related to study treatment. The incidence of death was lower in the intravenous ferumoxytol arm (1.1%) compared to the oral iron arm (2.8%). For deaths that occurred within thirty days of the last study treatment, the incidence was also lower with intravenous ferumoxytol, at 0.7%, compared to 1.4% among oral iron subjects. The overall incidences of adverse events (AE) and serious adverse events (SAE) occurring after study treatment were lower following ferumoxytol treatment than following oral iron treatment. The AE rate was 44.0% among ferumoxytol subjects compared to 53.9% among oral iron subjects, and the SAE rate was 9.8% among ferumoxytol subjects compared to 12.1% among oral iron subjects. A NDA for intravenous ferumoxytol is currently under review by the FDA.