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news.Amag Pharmaceuticals has submitted a new drug application to the FDA for marketing approval of ferumoxytol as an intravenous treatment of iron deficiency anemia in patients with chronic kidney disease, including dialysis dependent and non-dialysis dependent patients.
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The new drug application (NDA) is supported by data from three open-label, multi-center, randomized phase III efficacy and safety clinical studies and a fourth phase III safety study. The three efficacy and safety studies demonstrated a statistically significant achievement of all primary and secondary endpoints.
Brian Pereira, president and CEO of Amag, said: “This NDA submission is a great accomplishment for Amag and represents a major milestone in our development program for ferumoxytol. We are committed to bringing novel therapies to the market that can improve the lives of CKD patients. In the US there are an estimated 26 million adults living with chronic kidney disease. We believe that ferumoxytol has the potential to address iron deficiency anemia in this patient population and provide a more convenient and efficient method of intravenous iron administration.”