Takeda Pharmaceutical Company Limited and AMAG Pharmaceuticals, Inc. today announced the granting of marketing authorization by the European Commission (EC) for ferumoxytol, a new intravenous (IV) iron therapy to treat iron deficiency anemia (IDA) in adult patients with chronic kidney disease (CKD). The marketing authorization follows a positive opinion issued on April 19, 2012, by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). 

Across the three pivotal Phase III safety and efficacy studies, 1,726 subjects were exposed to ferumoxytol, including 1,562 patients with all stages of CKD; in which ferumoxytol was administered as a rapid injection.[1,2,3] From these studies, ferumoxytol significantly increased hemoglobin levels as compared to oral iron across the spectrum of CKD.[1,2,3] Moreover, ferumoxytol was well tolerated by CKD patients with IDA and had a similar overall treatment-related adverse event rate to oral iron.[1] These outcomes were further supported by additional retrospective observational data from three large haemodialysis clinics in the United States involving more than 8,600 patients and more than 33,300 administered doses of ferumoxytol.[4,5] 

 Iron deficiency is a common cause of anemia often seen in the later stages of CKD, as renal function deteriorates and erythropoiesis (red blood cell production) declines. IDA can have a profound impact on patients' lives, causing fatigue, shortness of breath and an increase in the risk of cardiovascular (CV) complications including congestive heart failure. [6,7]

 "While treatments for iron deficiency anemia have been widely available for many years, the disease continues to place a significant burden on the everyday life of CKD patients worldwide, and its management should be tailored to appropriately address the clinical consequences of this debilitating condition" says Francesco Locatelli, Scientific Director, Division of Nephrology and Dialysis, Alessandro Manzoni Hospital, Lecco, Italy. "Ferumoxytol offers an effective and convenient alternative to current therapies in the management of anaemia, and news of its approval will be warmly received by the renal community."


[1} Spinowitz BS, Kausz AT, Baptista J, et al. Ferumoxytol for treating iron deficiency anemia in CKD. J Am Soc Nephrol 2008; 19: 1599-1605.

[2] AMAG Pharmaceuticals. Data on file.

[3] Provenzano R, Schiller B, Rao M, et al. Clin J Am Soc Nephrol 2009; 4: 386-393. 

[4] Schiller B, Bhat P, Sharma A, et al. Safety of Feraheme® (Ferumoxytol) in hemodialysis patients at 3 dialysis chains over a 1-year period. J Am Soc Nephrol 2011; 22: 477A-478A. Abstr FR-PO1573.

[5] Sharma A, Bhat P, Schiller B, et al. Efficacy of Feraheme® (Ferumoxytol) administration on target hemoglobin levels and other iron parameters across 3 dialysis chains. J Am Soc Nephrol 2011; 22: 485A. Abstr FR-PO1603.

[6] O'Mara NB. Anemia in patients with chronic kidney disease. Diabetes Spectrum 2008; 21: 12-19.

[7] National Kidney Foundation. KDOQI clinical practice guidelines and clinical practice recommendations for anemia in chronic kidney disease. Am J Kidney Dis 2006; 47:S11-15.