AMAG Pharma's (AMAG) Feraheme Met Primary Endpoint in IDA Patients
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AMAG Pharmaceuticals, Inc. (Nasdaq: AMAG) today announced new clinical data for ferumoxytol (Feraheme), 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:
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.
- he 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.
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