.LEXINGTON, Mass.--(BUSINESS WIRE)-- AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG - News) 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.”
These results will be presented on Poster Board #LB-PO3156, Saturday, Nov. 12, 2011, 9:30 a.m. – 2:30 p.m.
About AMAG Pharmaceuticals, Inc.
AMAG Pharmaceuticals, Inc. is a biopharmaceutical company that manufactures and markets Feraheme® in the United States. For additional company information, please visit www.amagpharma.com.
AMAG Pharmaceuticals and Feraheme are registered trademarks of AMAG Pharmaceuticals, Inc.
About Feraheme
In the United States, Feraheme® (ferumoxytol) Injection for Intravenous (IV) use is indicated for the treatment of iron deficiency anemia in adult chronic kidney disease (CKD) patients. Feraheme received marketing approval from the U.S. Food and Drug Administration on June 30, 2009 and was commercially launched by AMAG in the U.S. shortly thereafter. For additional product information, please visit www.feraheme.com.
The important safety information below is based on the United States prescribing information.
Important Safety Information About Feraheme
Indication and contraindications
Feraheme is indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease. Feraheme is contraindicated in patients with known hypersensitivity to Feraheme or any of its components.
Warnings and precautions
Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Feraheme. Observe patients for signs and symptoms of hypersensitivity during and after Feraheme administration for at least 30 minutes and until clinically stable following completion of each administration. Only administer the drug when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions. Anaphylactic type reactions, presenting with cardiac/cardiorespiratory arrest, clinically significant hypotension, syncope, and unresponsiveness have been reported in the post-marketing experience. In clinical studies, serious hypersensitivity reactions were reported in 0.2% (3/1,726) of subjects receiving Feraheme. Other adverse reactions potentially associated with hypersensitivity (e.g., pruritus, rash, urticaria or wheezing) were reported in3.7% (63/1,726) of subjects. Severe adverse reactions of clinically significant hypotension have been reported in the post-marketing experience. In clinical studies, hypotension was reported in 1.9% (33/1,726) of subjects, including three patients with serious hypotensive reactions. Monitor for signs and symptoms of hypotension following each Feraheme injection. Excessive therapy with parenteral iron can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis. Patients should be regularly monitored for hematologic response during parenteral iron therapy, noting that lab assays may overestimate serum iron and transferrin bound iron values in the 24 hours following administration of Feraheme. As a superparamagnetic iron oxide, Feraheme may transiently affect magnetic resonance diagnostic imaging studies for up to 3 months following the last Feraheme dose. Feraheme will not affect X-ray, CT, PET, SPECT, ultrasound, or nuclear imaging.
Adverse reactions
In clinical trials, the most commonly occurring adverse reactions in Feraheme treated patients versus oral iron treated patients reported in = 2% of chronic kidney disease patients were diarrhea (4.0% vs. 8.2%), nausea (3.1% vs. 7.5%), dizziness (2.6% vs. 1.8%), hypotension (2.5% vs. 0.4%), constipation (2.1% vs. 5.7%) and peripheral edema (2.0% vs. 3.2%). In clinical trials, adverse reactions leading to treatment discontinuation and occurring in 2 or more Feraheme treated patients included hypotension, infusion site swelling, increased serum ferritin level, chest pain, diarrhea, dizziness, ecchymosis, pruritus, chronic renal failure, and urticaria.
Post-marketing safety experience
The following adverse reactions have been identified during post-approval use of Feraheme. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The following serious adverse reactions have been reported from the post-marketing spontaneous reports with Feraheme: life-threatening anaphylactic-type reactions, cardiac/cardiorespiratory arrest, clinically significant hypotension, syncope, unresponsiveness, loss of consciousness, tachycardia/rhythm abnormalities, angioedema, ischemic myocardial events, congestive heart failure, pulse absent, and cyanosis. These adverse reactions have occurred up to 30 minutes after the administration of Feraheme injection. Reactions have occurred following the first dose or subsequent doses of Feraheme.
For full prescribing information, please visit www.feraheme.com.
Contact:. AMAG Pharmaceuticals, Inc. Amy Sullivan, 617-498-3303 or Media Contact: Feinstein Kean Healthcare Lynn Blenkhorn, 508-851-0930.
