Prescription Drug User Fee Act (PDUFA) Target Action Date of February 2, 2018 Established
WALTHAM, Mass., Aug. 31, 2017 (GLOBE NEWSWIRE) — AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that the U.S. Food and Drug Administration (FDA) accepted its submission to broaden the existing label for Feraheme® (ferumoxytol) to include the treatment of all adults with iron deficiency anemia (IDA) who have an intolerance or unsatisfactory response to oral iron. The FDA has indicated a six-month review timeline and established a Prescription Drug User Fee Act (PDUFA) target action date of February 2, 2018. The current indication of Feraheme is limited to the treatment of IDA in adults with chronic kidney disease (CKD).
“The acceptance of our Feraheme label extension filing marks an important milestone in our effort to bring Feraheme to the more than 4.5 million Americans who have been diagnosed with IDA and suffer from its debilitating effects1,” said Julie Krop, M.D., chief medical officer and senior vice president of clinical development and regulatory affairs at AMAG. “A significant proportion of these patients are women with IDA who suffer from gynecological issues, including abnormal uterine bleeding. We look forward to leveraging our deep relationships and expertise in women’s health to bring a potential new treatment option to this underserved population.”
The submission is, in part, supported by positive results from a previously announced Phase 3 randomized, double-blind, non-inferiority clinical trial that evaluated Feraheme compared to Injectafer® (ferric carboxymaltose injection) in approximately 2,000 adults with IDA who had failed or could not tolerate oral iron or in whom oral iron was contraindicated. The study met its pre-specified primary endpoint of demonstrating non-inferiority to Injectafer® based on the primary composite endpoint of the incidence of moderate-to-severe hypersensitivity reactions (including anaphylaxis) or moderate-to-severe hypotension. To read the full press release on these top-line study results please click here.
About Feraheme® (ferumoxytol)
Feraheme received marketing approval from the FDA in June 2009 for the treatment of IDA in adult CKD patients and was commercially launched by AMAG in the U.S. shortly thereafter. Ferumoxytol is protected in the U.S. by seven issued patents covering the composition and dosage form of the product. Six of the issued patents are listed in the FDA’s Orange Book, the last of which expires in June 2023.
Fatal and serious hypersensitivity reactions including anaphylaxis have occurred in patients receiving Feraheme. Initial symptoms may include hypotension, syncope, unresponsiveness, cardiac/cardiorespiratory arrest. Feraheme is contraindicated in patients with a known hypersensitivity to Feraheme or any of its components, or a history of allergic reaction to any intravenous iron product.
For additional product information, please see full Prescribing Information, including Boxed Warning, available at www.feraheme.com.
AMAG is a biopharmaceutical company focused on developing and delivering important therapeutics, conducting clinical research in areas of unmet need and creating education and support programs for the patients and families we serve. Our currently marketed products support the health of patients in the areas of maternal and women’s health, anemia management and cancer supportive care. Through CBR®, we also help families to preserve newborn stem cells, which are used today in transplant medicine for certain cancers and blood, immune and metabolic disorders, and have the potential to play a valuable role in the ongoing development of regenerative medicine. For additional company information, please visit www.amagpharma.com.
This press release contains forward-looking information about AMAG Pharmaceuticals, Inc. within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Any statements contained herein which do not describe historical facts, including, among others, AMAG’s beliefs regarding the study data, AMAG’s belief regarding its’ ability to leverage its’ deep relationships and expertise in women’s health to bring a potential new treatment option to an underserved population; and beliefs that newborn stem cells have the potential to play a valuable role in the development of regenerative medicine 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, among others, those risks identified in AMAG’s filings with the U.S. Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2016, its Quarterly Report on Form 10-Q for the quarters ended March 31, 2017 and June 30, 2017 and subsequent filings with the SEC. Any such risks and uncertainties could materially and adversely affect AMAG’s results of operations, its profitability and its cash flows, which would, in turn, have a significant and adverse impact on AMAG’s stock price. AMAG cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made.
AMAG disclaims 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® and Feraheme® are registered trademarks of AMAG Pharmaceuticals, Inc. CBR® is a registered trademark of Cbr Systems, Inc.
1 Global Intravenous (I.V.) Iron Drugs Market Report: 2015 Edition.
AMAG Pharmaceuticals, Inc. Contacts: Investors: Linda Lennox Vice President, Investor Relations 908-627-3424 Media: Katie Payne Vice President, External Affairs 202-669-6786
AMAG Pharmaceuticals, Inc.