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news.Amag Pharmaceuticals has reported that the new drug application for ferumoxytol in chronic kidney disease or CKD has been accepted for standard review by the FDA.
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The company is seeking marketing approval for ferumoxytol as an intravenous treatment of iron deficiency anemia in patients with CKD, including dialysis dependent and non-dialysis dependent patients. The company expects FDA action on the NDA by late October 2008.
The NDA is supported by data from four Phase III studies, which consisted of three open-label, multi-center, randomized efficacy and safety clinical studies and a fourth double-blind, multi-center, randomized, placebo-controlled safety study. The results of each of the three efficacy and safety studies demonstrated a statistically significant achievement of all primary and secondary efficacy endpoints. In total, over 1,700 patients and healthy volunteers were treated with ferumoxytol in the company’s eleven clinical studies.
Brian Pereira, president and CEO of Amag, said: “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.”