AMAG Pharmaceuticals (AMAG) Reports Preliminary Data for the Safety & Efficacy of Single Infusion of 1020 mg Ferumoxytol
Tweet
Share
E-mailGet Alerts AMAG Hot Sheet
Join SI Premium – FREE
AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced new clinical data for ferumoxytol, 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 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.
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- Milestone Pharmaceuticals starts Phase 3 AFib-RVR trial for etripamil
- Korro Bio files ethics submission for urea cycle disorder drug trial
- Radiopharm trial advances to higher dose in HER2+ cancer study
Create E-mail Alert Related Categories
FDASign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!
