Ferumoxytol Resubmission Designated Complete, Class 1 Response By FDA - Iron Deficiency Anemia In Chronic Kidney Disease Patients
September 18, 2017
AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that the U.S. Food and Drug Administration (FDA) has designated the Company's resubmission to the October 2008 Complete Response letter for its New Drug Application (NDA) for ferumoxytol as a complete, Class 1 response. The FDA has established a December 30, 2008 Prescription Drug User Fee Act (PDUFA) target action date. AMAG is seeking marketing approval for ferumoxytol for the treatment of iron deficiency anemia in patients with all stages of chronic kidney disease (CKD), including those on dialysis and those not on dialysis.
"We are pleased that the FDA has designated our resubmission as a complete, Class 1 response," stated Brian J.G. Pereira, M.D., President and Chief Executive Officer of AMAG Pharmaceuticals, Inc. "We look forward to continuing to work with the Agency to complete the review of the ferumoxytol resubmission. We plan to launch ferumoxytol shortly after we receive approval."
About AMAG Pharmaceuticals, Inc.
AMAG Pharmaceuticals, Inc. is a biopharmaceutical company that utilizes its proprietary technology for the development and commercialization of a therapeutic iron compound to treat anemia and novel imaging agents to aid in the diagnosis of cancer and cardiovascular disease. amagpharma
Ferumoxytol is being developed for use as an intravenous iron replacement therapeutic agent for the treatment of iron deficiency anemia and as a diagnostic agent for vascular-enhanced magnetic resonance imaging to assess peripheral arterial disease. In December 2007, the Company submitted a New Drug Application (NDA) to the FDA for marketing approval of ferumoxytol as an intravenous iron replacement therapy in chronic kidney disease patients. In October 2008, the Company received a Complete Response letter from the FDA with respect to its NDA requesting certain additional information prior to the approval of ferumoxytol for marketing and sale in the U.S.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and federal securities laws. Any statements contained herein which do not describe historical facts, including but not limited to, statements regarding launching ferumoxytol shortly after the Company receives approval of ferumoxytol, are forward looking statements which 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: (1) The possibility that we may not be able to adequately address the issues raised and provide the information requested by the FDA in the ferumoxytol complete response letter and obtain the necessary regulatory approvals in order to market and sell ferumoxytol, or the possibility that we may not be able address such issues, provide such information or obtain such approvals in a timely manner, (2) the fact that we have limited sales and marketing expertise, (3) uncertainties regarding our ability to successfully compete in the intravenous iron replacement and imaging markets, (4) uncertainties regarding our ability to obtain favorable coverage, pricing and reimbursement for ferumoxytol, if approved, (5) uncertainties regarding our ability to manufacture ferumoxytol, (6) uncertainties relating to our patents and proprietary rights, and (7) other risks identified in our Securities and Exchange Commission filings, including our most recent Annual Report on Form 10-K.
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.
AMAG Pharmaceuticals, Inc.