AMAG Pharmaceuticals, Inc., of Cambridge, Mass., has announced that the FDA has accepted for standard review its New Drug Application (NDA) for ferumoxytol as an IV treatment of iron deficiency anemia in CKD patients.
The results from four open-label, multicenter, randomized phase III studies demonstrated statistically significant achievement of all primary and secondary efficacy end points. In total, more than 1,700 patients and healthy volunteers were treated with ferumoxytol in 11 clinical studies.
“We believe that ferumoxytol has the potential to address the treatment of iron deficiency anemia in CKD patients and provide a more convenient and efficient method of intravenous iron administration,” stated Brian J.G. Pereira, MD, president and chief executive officer of AMAG.
The company expects FDA action on the NDA by late October.