AMAG Pharma Submits Supplemental NDA for Feraheme

AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced that it hassubmitted a supplemental new drug application (sNDA) to the United States Foodand Drug Administration (FDA) for Feraheme® (ferumoxytol) Injection forIntravenous (IV) use. The sNDA requests FDA approval to expand the indicationfor ferumoxytol beyond the current indication for the treatment of irondeficiency anemia (IDA) in adult patients with chronic kidney disease (CKD) toall adult patients with IDA who have failed or could not tolerate oral irontreatment. The application includes data from two well-controlled phase IIIclinical trials of more than 1,400 patients.The sNDA submission is based on data from a global phase III program thatevaluated the use of ferumoxytol in a broad range of adult IDA patients, allof whom had failed or could not tolerate oral iron treatment. More than 1,400patients were enrolled in the two phase III clinical trials, IDA-301 (placebocomparator) and IDA-302 (active comparator). Both studies achieved theirprimary efficacy endpoints, with meaningful improvements in hemoglobin frombaseline to the 35-day endpoint of the studies. Adverse events and seriousadverse events associated with IV iron therapy, including hypersensitivityreactions, were reported in both studies. No new safety signals, outside ofthose described in the current Feraheme® (ferumoxytol) label, were observedwith ferumoxytol treatment in these studies. These clinical trials alsoincluded patient-reported outcomes data as pre-specified secondary andexploratory endpoints. These outcomes endpoints, including quantitativemeasures of patients' fatigue and measures of quality of life, captured thenegative pre-treatment impact anemia has on these patients' lives – and thesignificant improvement in these scores following a one gram course of therapywith ferumoxytol.