Data Shows Patients Treated with Feraheme® (ferumoxytol) were Less Likely to Develop Severe
Hypophosphatemia Compared to Those Treated with a Comparator IV Iron
"The data showed that severe hypophosphatemia occurred in 38.7 percent of patients on ferric carboxymaltose injection compared to 0.4 percent of patients treated with ferumoxytol," said Dr.
In the Phase 3 trial, of the 997 patients treated with Feraheme, severe hypophosphatemia occurred in 4 people compared to 397 out of 1,000 people treated with Injectafer®. Among patients receiving standard courses of Injectafer® (750mg x 2 doses), mean blood phosphorus levels decreased [from baseline] at all time points (day 8, week 2 and week 5) compared to Feraheme (510 mg x 2 doses). Severe hypophosphatemia is defined as a serum phosphate level of less than 2.0 mg/dL (0.6 mmol/L).
“Phosphate is required for a broad array of cellular processes and provides mineral strength to bone,” said
About The Phase 3 Trial
The study results demonstrated non-inferiority to Injectafer® based on the primary composite endpoint of incidence of moderate-to-severe hypersensitivity reactions (including anaphylaxis) and moderate-to-severe hypotension. Additionally, the trial met secondary safety and efficacy endpoints, including the demonstration of superiority to Injectafer® in mean improvement in hemoglobin per gram of iron administered from baseline to week 5. To read the full press release on these top-line trial results please click here.
Based, in part, upon these trial results, AMAG completed the submission to the
About Feraheme® (ferumoxytol)
Feraheme received marketing approval from the
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 and how important the incidence of severe hypophosphatemia may be to prescribing physicians; AMAG’s beliefs about the importance of serum phosphate and the long term consequences associated with hypophosphatemia, such as bone pain, weakness, asthenia, and osteomalacia; 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 (
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
Vice President, Investor Relations
Source: AMAG Pharmaceuticals, Inc.