Nanotechnology Now

Our NanoNews Digest Sponsors


Heifer International

Wikipedia Affiliate Button


DHgate

Home > Press > AMAG Pharmaceuticals, Inc. Announces FDA Acceptance for Filing of Ferumoxytol New Drug Application in Chronic Kidney Disease

Abstract:
AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced that the New Drug Application (NDA) for ferumoxytol in chronic kidney disease (CKD) has been accepted for standard review by the U.S. Food and Drug Administration (FDA). The Company is seeking marketing approval for ferumoxytol as an intravenous treatment of iron deficiency anemia in patients with CKD, including dialysis dependent and non-dialysis dependent patients. The Company expects FDA action on the NDA by late October 2008.

AMAG Pharmaceuticals, Inc. Announces FDA Acceptance for Filing of Ferumoxytol New Drug Application in Chronic Kidney Disease

Cambridge, MA | Posted on February 19th, 2008

The NDA is supported by data from four Phase III studies, which consisted of three open-label, multi-center, randomized efficacy and safety clinical studies and a fourth double-blind, multi-center, randomized, placebo-controlled safety study. The results of each of the three efficacy and safety studies demonstrated a statistically significant achievement of all primary and secondary efficacy endpoints. In total, over 1,700 patients and healthy volunteers were treated with ferumoxytol in the Company's eleven clinical studies.

"We are very pleased to receive the acceptance for filing of our NDA for ferumoxytol," stated Brian J.G. Pereira, M.D., President and Chief Executive Officer of AMAG. "We believe that ferumoxytol has the potential to address the treatment of iron deficiency anemia in CKD patients and provide a more convenient and efficient method of intravenous iron administration."

About Chronic Kidney Disease

Kidney disease is the ninth leading cause of death in the United States1. CKD is associated with premature mortality, decreased quality of life, and increased health care expenditures. CKD can progress to end-stage renal disease and require dialysis or kidney transplantation. The U.S. Renal Data System estimated that in 2005 the dialysis population was over 340,000 patients2.

Sources:

1. Arias E, Anderson RN, Kung HC, Murphy SL, Kockanek KD. Deaths: Final data for 2001. National Vital Statistics Reports 2003;52(3):1-115.

2. End-Stage Renal Disease Incidence and Prevalence: United States Renal Data Systems 2007 Annual Data Report. 2007, pp 81-98.

####

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, as well as novel imaging agents to aid in the diagnosis of cancer and cardiovascular disease.

Ferumoxytol, the Company’s key product candidate, is being developed for use as an intravenous iron replacement therapeutic for the treatment of iron deficiency anemia in patients with CKD. The Company has released data on all four of its planned Phase III clinical trials of ferumoxytol as an intravenous iron replacement therapeutic in patients with CKD. The Company submitted the NDA to the FDA in December 2007.

This document contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Any statements contained in this press release that do not describe historical facts, including but not limited to, statements that we believe ferumoxytol has the potential to address iron deficiency anemia in CKD patients and provide a more convenient and efficient method of intravenous iron administration, are forward-looking statements that involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements. Such risks and uncertainties include the following: (1) the possibility that we may not be able to obtain the necessary regulatory approvals in order to market and sell ferumoxytol, or we may not obtain such approvals in a timely manner due to deficiencies in the design or oversight by us of these trials, the failure of our trials to demonstrate that ferumoxytol is safe and efficacious, or any other factor causing an increase in expenses, a delay and/or a negative effect on the results of the clinical studies for ferumoxytol; (2) the fact that we have limited sales and marketing expertise; (3) uncertainties regarding our ability to successfully compete in the intravenous iron replacement market; (4) uncertainties regarding our ability to obtain favorable coverage, pricing and reimbursement for ferumoxytol, if approved; (5) uncertainties regarding our ability to manufacture sufficient quantities of ferumoxytol to meet demand, if approved; (6) uncertainties relating to our patents and proprietary rights; and (7) other risks identified in our Securities and Exchange Commission filings. We caution readers not to place undue reliance on any forward-looking statements which speak only as of the date they are made. We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.

For more information, please click here

Contacts:
AMAG Pharmaceuticals, Inc.
Kristen Galfetti, 617-498-3362

Copyright © Business Wire 2008

If you have a comment, please Contact us.

Issuers of news releases, not 7th Wave, Inc. or Nanotechnology Now, are solely responsible for the accuracy of the content.

Bookmark:
Delicious Digg Newsvine Google Yahoo Reddit Magnoliacom Furl Facebook

Related News Press

News and information

Animal study shows flexible, dissolvable silicon device promising for brain monitoring: Other applications include post-operative observation for vascular, cardiac, and orthopaedic procedures, finds Penn study May 5th, 2016

Speedy ion conduction in solid electrolytes clears road for advanced energy devices May 5th, 2016

Engineers create a better way to boil water -- with industrial, electronics applications May 5th, 2016

Clues on the path to a new lithium battery technology: Charging produces highly reactive singlet oxygen in lithium air batteries May 5th, 2016

Govt.-Legislation/Regulation/Funding/Policy

Animal study shows flexible, dissolvable silicon device promising for brain monitoring: Other applications include post-operative observation for vascular, cardiac, and orthopaedic procedures, finds Penn study May 5th, 2016

Speedy ion conduction in solid electrolytes clears road for advanced energy devices May 5th, 2016

Engineers create a better way to boil water -- with industrial, electronics applications May 5th, 2016

Clues on the path to a new lithium battery technology: Charging produces highly reactive singlet oxygen in lithium air batteries May 5th, 2016

Nanomedicine

Animal study shows flexible, dissolvable silicon device promising for brain monitoring: Other applications include post-operative observation for vascular, cardiac, and orthopaedic procedures, finds Penn study May 5th, 2016

Unique nano-capsules promise the targeted drug delivery: Russian scientists created unique nano-capsules for the targeted drug delivery May 5th, 2016

The intermediates in a chemical reaction photographed 'red-handed' Researchers at the UPV/EHU-University of the Basque Country have for the first time succeeded in imaging all the steps in a complex organic reaction and have resolved the mechanisms that explain it May 4th, 2016

Nuclear pores captured on film: Using an ultra fast-scanning atomic force microscope, researchers from the University of Basel have filmed 'living' nuclear pore complexes at work for the first time May 3rd, 2016

Announcements

Speedy ion conduction in solid electrolytes clears road for advanced energy devices May 5th, 2016

Engineers create a better way to boil water -- with industrial, electronics applications May 5th, 2016

Clues on the path to a new lithium battery technology: Charging produces highly reactive singlet oxygen in lithium air batteries May 5th, 2016

Unique nano-capsules promise the targeted drug delivery: Russian scientists created unique nano-capsules for the targeted drug delivery May 5th, 2016

NanoNews-Digest
The latest news from around the world, FREE




  Premium Products
NanoNews-Custom
Only the news you want to read!
 Learn More
NanoTech-Transfer
University Technology Transfer & Patents
 Learn More
NanoStrategies
Full-service, expert consulting
 Learn More











ASP
Nanotechnology Now Featured Books




NNN

The Hunger Project







Car Brands
Buy website traffic