AMAG Pharmaceuticals Announces Preliminary Data Regarding the Safety and Efficacy of a Single Infusion of 1020 mg Ferumoxytol (Feraheme[R]) in Patients with Iron Deficiency Anemia.
LEXINGTON, Mass. -- AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced new clinical data for ferumoxytol (Feraheme[R]), the company's treatment for iron deficiency anemia (IDA) in adult patients with chronic kidney disease (CKD). These data were presented on Saturday, December 10, 2011, at a poster session at the American Society of Hematology annual meeting in San Diego, CA.
The poster titled, "Safety and Efficacy of Total Dose Infusion of Ferumoxytol 1020 mg Administered in 15 Minutes" (Auerbach, et al.) presents the results from a single-arm, open-label, single-center clinical trial in which 36 patients with IDA received a single dose of 1020 mg of ferumoxytol diluted in 100 mL normal saline via infusion pump over 15 minutes. Ferumoxytol is currently labeled to be administered as two 510 mg doses, separated by 3 to 8 days. The primary endpoint was to examine the safety and tolerability of ferumoxytol administered as 1020 mg through the rate of adverse event (AE) reports collected on the day of dosing and through phone calls 1, 2, and 7 days post-dosing. Safety was also assessed through the measurement of vital signs through 1 hour post-dosing. The secondary endpoint was to evaluate the efficacy of ferumoxytol by examining changes in hemoglobin (Hgb), transferrin saturation (TSAT), ferritin, and red blood cell distribution (RDW) at 4 and 8 weeks post-dose.
The overall results from the study are presented below:
* No serious adverse events were reported.
* Of the non-serious AEs reported, all resolved without therapy. Five of the 16 patients who experienced non-serious AEs had a known medication allergy.
* A majority of patients achieved a 1 g/dL rise in Hgb from Baseline: 86% at Week 4 and 87% at Week 8.
* A majority of patients achieved a 2 g/dL rise in Hgb from Baseline: 61% at Week 4 and 70% at Week 8.
* The pattern regarding red blood cell distribution through Week 8 was reflective of an ongoing hematopoietic response: 16.5% at Baseline, 20.2% at Week 4, and 19.0% at Week 8.
"These preliminary data show that ferumoxytol, administered to patients with IDA in a single infusion of 1020 mg, generated no serious adverse events, and only 16 out of 36 patients experienced minor adverse events. The secondary endpoint data suggest that ferumoxytol is efficacious when administered in a 1020 mg infusion in patients with IDA," said Michael Auerbach, MD, FACP, Auerbach Hematology and Oncology Associates, Inc. "If these results are confirmed through randomized controlled trials, this single total dose infusion of ferumoxytol would provide an alternative method for the treatment of IDA for both patients and clinicians."
About AMAG Pharmaceuticals, Inc.
AMAG Pharmaceuticals, Inc. is a biopharmaceutical company that manufactures and markets Feraheme[R] in the United States. For additional company information, please visit www.amagpharma.com.
AMAG Pharmaceuticals and Feraheme are registered trademarks of AMAG Pharmaceuticals, Inc.
In the United States, Feraheme[R] (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.
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.
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|Date:||Dec 12, 2011|
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