Achieved all primary and secondary safety and efficacy endpoints
On track to file sNDA mid-year with a potential approval and launch in first half of 2018
Company to discuss clinical data on first quarter earnings call today at
“We believe this successful head-to-head, Phase 3 clinical trial marks an important milestone on our path toward gaining
Approximately 2,000 patients diagnosed with IDA regardless of underlying etiology were randomized in a 1:1 ratio into one of two treatment groups – 1.02 grams of Feraheme intravenous (IV) infusion (n=997) or 1.5 grams of Injectafer IV infusion (n=1,000).
Feraheme met the study’s primary endpoint demonstrating non-inferiority to Injectafer (based on an NI margin of 2.64%) with respect to the percentage of patients who experienced moderate-to-severe hypersensitivity reactions (including anaphylaxis) and/or moderate-to-severe hypotension (Feraheme: 0.6%; Injectafer: 0.7%; treatment difference: -0.1%; 95% confidence interval: -0.80% to +0.61%; NI p=<0.0001). Feraheme also demonstrated non-inferiority to Injectafer for a secondary composite safety endpoint assessing incidence of moderate-to-severe hypersensitivity reactions (including anaphylaxis), serious cardiovascular events, and/or death (based on an NI margin of 3.6%) (Feraheme: 1.3%; Injectafer: 2.0%; treatment difference: -0.7%; 95% confidence interval: -1.81% to +0.42%; NI p=<0.0001).
With regards to secondary composite efficacy endpoints, the study demonstrated superiority of Feraheme to Injectafer in mean increase from baseline to week 5 in hemoglobin per gram of iron administered (Feraheme: 1.36 g/dL per gram of iron; Injectafer: 1.09 g/dL per gram of iron; treatment difference 0.27 g/dL per gram of iron; 95% confidence interval +0.17 g/dL per gram of iron to +0.36 g/dL per gram of iron; superiority p-value= <.0001). Feraheme also successfully demonstrated non-inferiority to Injectafer (based on an NI margin of 0.5 g/dL) comparing mean improvement in hemoglobin from baseline to week 5 (Feraheme: 1.38 g/dL; Injectafer: 1.62 g/dL; treatment difference: -0.24 g/dL; 95% confidence interval: -0.35 g/dL to -0.12 g/dL; NI p=<0.0001).
Importantly, the study also showed a markedly greater incidence of hypophosphatemia (an exploratory endpoint defined by blood phosphorous of <0.6 mmol/L at week 2) in the patients dosed with Injectafer versus those dosed with Feraheme (Feraheme: 0.4% of patients; Injectafer: 38.6% of patients; treatment difference: -38.2%; 95% confidence interval: -41.31% to ‑35.06%; superiority p-value p<.0001).
AMAG expects to file a supplemental new drug application (sNDA) with the
"Today, only half of the patients living with iron deficiency anemia are covered by Feraheme’s current label. If approved, the broader indication doubles the immediate market opportunity for Feraheme and provides opportunity for significant future market growth with our existing sales force and their strong customer relationships,” said
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 women’s and maternal 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
Such risks and uncertainties include, among others, those risks identified in AMAG’s filings with the
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 trademark of
AMAG Pharmaceuticals, Inc.Contacts: Investors: Linda LennoxVice President, Investor Relations 908-627-3424 Media: Katie PayneVice President, External Affairs 202-669-6786