Feraheme as safe and effective as iron sucrose in patients with anemia, CKD

AMAG Pharmaceuticals, Inc.Nov 14 2011

AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced positive new data from the FIRST head-to-head trial comparing Feraheme® (ferumoxytol) Injection for intravenous (IV) use to iron sucrose in patients with iron deficiency anemia and chronic kidney disease (CKD). The data are being presented today in the late-breaking clinical trials poster session at the American Society of Nephrology Kidney Week meeting in Philadelphia, PA.

The poster titled, "The FIRST Head-to-head Comparison Study (Ferumoxytol Compared to Iron Sucrose Trial) of the Safety and Efficacy of Ferumoxytol with Iron Sucrose for the Treatment of Iron Deficiency Anemia in Patients with Chronic Kidney Disease" (Macdougall, et al.) presents results from a randomized, open-label, multicenter, international trial that enrolled 162 subjects with iron deficiency anemia and either dialysis-dependent or non-dialysis dependent CKD. Subjects were randomly assigned to receive ferumoxytol or iron sucrose in a 1:1 ratio. The primary objective of the study was to evaluate the safety of ferumoxytol compared to iron sucrose. Exploratory efficacy analyses compared ferumoxytol to iron sucrose by assessing changes in hemoglobin and percent responders. Overall, this randomized controlled clinical trial demonstrated that ferumoxytol 1.02 g, delivered as two injections of 510 mg within 5±3 days, had a favorable safety profile and comparable efficacy to 1 g of iron sucrose dosed as 100 mg or 200 mg over 5 to 10 injections given over 2 to 2.5 weeks. Dr. Iain Macdougall, professor of clinical nephrology at King's College Hospital in London, was the lead author on the study.

Safety and efficacy data in the poster include:

• Patients treated with ferumoxytol had lower overall rates of adverse events (48% vs. 65%), related adverse events (10% vs. 16%), and adverse events leading to drug discontinuation (1% vs. 5%) compared to patients treated with iron sucrose.
• Serious adverse events (SAEs), related SAEs, and AEs of special interest (hypotension and hypersensitivity reactions) were similar between the two treatment groups.
• Ferumoxytol-treated patients had a comparable increase in hemoglobin (Hgb) at Week 5 from baseline compared with patients treated with iron sucrose, however, higher Hgb values were observed at all time points following treatment through Week 5 in ferumoxytol-treated patients compared to patients treated with iron sucrose.
• More ferumoxytol-treated patients (50%) achieved a ≥1 g/dL increase in Hgb compared with patients treated with iron sucrose (42%).
• Ferumoxytol-treated patients had a faster time to response (28.5 days vs. 32.9 days) (defined as an increase in Hgb of ≥1 g/dL or achieved ≥12 g/dL from Baseline) than did patients treated with iron sucrose.

"This is an exciting time in the treatment of iron deficiency anemia with products such as ferumoxytol that can be administered at a much higher dose than was possible previously," said Lee F. Allan, M.D., Ph.D., chief medical officer of AMAG. "While this was not a large study, this randomized, controlled study is one of few head-to-head studies of IV iron products. It is encouraging that the safety profile of ferumoxytol was favorable and showed similar efficacy to iron sucrose. If these results are confirmed in a larger study, then the convenience of being able to deliver 1g of IV iron within a time-frame of 3 - 8 days may translate into real benefits for patients and providers."