AMAG Pharmaceuticals Inc have announced that two posters on ferumoxytol will be presented today at the National Kidney Foundation (NKF) Spring Clinical Meetings in Dallas, Texas.
The first poster, “Evaluation of Ferumoxytol Safety and Efficacy in all Stages of Chronic Kidney Disease” presents results from the company’s three phase III efficacy and safety studies, which included 875 patients with all stages of chronic kidney disease (CKD). Patients received either two doses of 510mg intravenous (IV) ferumoxytol within approximately one week or 200mg of oral iron daily for three weeks and were followed for 35 days. Efficacy and safety were assessed overall and by stage of kidney disease. The aggregate results demonstrated that there was a statistically significant greater mean increase in haemoglobin from baseline to Day 35 in patients receiving ferumoxytol compared to patients receiving oral iron. When these results were stratified by stage of CKD, ferumoxytol treatment produced approximately a 1g/dl increase in hemoglobin from baseline to Day 35 for each stage.
The second poster, “Evaluation of the Safety of Ferumoxytol IV Iron Therapy in Peritoneal Dialysis Patients,” presents results from the company’s phase III, randomised, double-blind, placebo-controlled, crossover safety study. Safety results were evaluated in 40 peritoneal dialysis patients, in 255 haemodialysis patients, and in 413 non-dialysis dependent patients. Patients received one IV injection of either 510mg ferumoxytol or saline placebo at day zero and received the other treatment at day seven. Overall adverse event rates for patients on peritoneal dialysis were lower following ferumoxytol administration (12.5%) versus following placebo administration (20.5%), and drug-related adverse event rates were similar following ferumoxytol administration (5.0%) and placebo administration (7.7%).
“We are delighted to share additional positive analyses generated from our ferumoxytol pivotal studies at the NKF meeting this year,” stated Brian Pereira, MD, President and Chief Executive Officer of AMAG Pharmaceuticals. “We are committed to commercializing ferumoxytol for the treatment of iron deficiency anemia in CKD patients and look forward to a decision from the FDA in late October of this year regarding our New Drug Application.”