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AMAG Pharmaceuticals, Inc. Announces Presentation of Positive Results from Phase III Studies of Ferumoxytol as an Intravenous Iron Replacement Therapy in Kidney Transplant Recipients at the American Transplant Congress

AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG), a biopharmaceutical company that utilizes its proprietary nanoparticle technology for the development and commercialization of therapeutic iron compounds to treat anemia, and novel imaging agents to aid in the diagnosis of cancer and cardiovascular disease, today announced positive results from pooled data from two open-label, multicenter, randomized Phase III studies of ferumoxytol as an intravenous iron replacement therapeutic agent. The data are being presented at approximately 5:30 pm ET as a poster at the 8th American Transplant Congress in Toronto, Canada. The poster is available on the Companys website at www.amagpharma.com.

The poster, Ferumoxytol as an Intravenous Iron Replacement Therapy: Efficacy and Safety in Subjects with Functioning Kidney Transplants presents results from 31 patients with chronic kidney disease (CKD) stages 1-5 with functioning kidney transplants. Patients received either two doses of 510 mg of intravenous (IV) ferumoxytol within one week or 200 mg of oral iron daily for three weeks and were followed for 35 days. The pooled, post-hoc data demonstrated a statistically significant achievement of the primary endpoint in patients treated with ferumoxytol compared to those treated with oral iron. The primary endpoint was the mean change in hemoglobin from baseline at Day 35.

"We are very pleased to present these positive ferumoxytol results in CKD patients with functioning kidney transplants and iron deficiency anemia," stated Brian J.G. Pereira, MD, President and CEO of AMAG Pharmaceuticals Inc. "The treatment of iron deficiency anemia with IV iron has not been extensively studied in kidney transplant recipients. These data are consistent with previously reported ferumoxytol clinical results and suggest that ferumoxytol may also be useful in this patient subgroup."

Efficacy and Safety Information Included in Poster

The poster presents pooled results from two Phase III trials (ClinicalTrials.gov identifiers NCT00255437 and NCT00255424). Efficacy results from this post-hoc kidney transplant subset analysis showed:

  • For the primary endpoint, the mean change in hemoglobin from baseline at Day 35, there was a statistically significant greater mean (± standard deviation) increase in hemoglobin in patients receiving ferumoxytol compared with patients receiving oral iron (ferumoxytol 1.45 ± 1.27 g/dl vs. oral iron -0.09 ± 1.47 g/dl, p=0.035). There was also a statistically significantly greater mean increase in hemoglobin from baseline at Day 21 in patients receiving ferumoxytol compared with patients receiving oral iron (ferumoxytol 1.04 ± 0.97 g/dl vs. oral iron 0.23 ± 0.52 g/dl; p=0.035).
  • A higher proportion of ferumoxytol-treated patients compared with oral iron-treated patients achieved a 1.0 g/dL or greater rise in hemoglobin at Day 21 (47.8% vs. 12.5%; p=0.108) and Day 35 (60.9% vs. 25.0%; p=0.113).

The incidence of adverse events was lower in patients following ferumoxytol administration than after oral iron (47.8% vs. 75.0%), as was the incidence of serious adverse events (13.0% vs. 37.5%).

About AMAG Pharmaceuticals, Inc.

AMAG Pharmaceuticals, Inc. is a biopharmaceutical company that utilizes its proprietary nanoparticle technology for the development and commercialization of therapeutic iron compounds to treat anemia and novel imaging agents to aid in the diagnosis of cancer and cardiovascular disease.

Ferumoxytol, the Companys key product candidate, is being developed for use as an intravenous iron replacement therapeutic agent for the treatment of iron deficiency anemia in chronic kidney disease patients. The Company has released data on all four planned Phase III clinical trials of ferumoxytol as an intravenous iron replacement therapeutic agent in chronic kidney disease patients. The Company submitted a New Drug Application for marketing approval of ferumoxytol with the U.S. Food and Drug Administration (FDA) in December 2007, which was accepted for filing by the FDA in February 2008.

Contacts:

AMAG Pharmaceuticals, Inc.
Kristen Galfetti, 617-498-3362
kgalfetti@amagpharma.com

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