AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced that new data from two pivotal phase III clinical trials were presented at the American Society of Hematology’s (ASH) annual meeting in Atlanta, Georgia. The phase III trials evaluated the use of ferumoxytol in subjects with iron deficiency anemia (IDA), regardless of the underlying cause of the anemia, who had failed or could not tolerate oral iron treatment. New data from an investigator-initiated study evaluating a one gram 15-minute infusion of ferumoxytol are also being presented at ASH; the current approved dosing of ferumoxytol is two 510 mg injections, three to eight days apart.
Two poster sessions highlighted the safety and efficacy data from each of the phase III clinical trials: IDA-301 and IDA-302. In addition, an oral presentation contained patient-reported outcome data from IDA-301, which demonstrated a direct correlation between the rise in hemoglobin and improvement in patient-reported measures of fatigue. Data from these two clinical trials will be the foundation for AMAG’s supplemental new drug application (sNDA) in the United States.
More than 4 million Americans have iron deficiency anemia; 1.6 million of whom are estimated to have chronic kidney disease (CKD), while the other 2.4 million suffer from anemia due to other causes.
For these patients with anemia due to other causes, the underlying diseases or conditions causing IDA include abnormal uterine bleeding, gastrointestinal disorders, inflammatory diseases and chemotherapy-induced anemia. Many IDA patients fail treatment with oral iron due to intolerability or side effects.
AMAG's sNDA will seek to expand the use of Feraheme® (ferumoxytol) for all adult iron deficiency anemia patients with a history of unsatisfactory use of oral iron. The company expects to submit the sNDA to the U.S. Food and Drug Administration (FDA) this month. In the United States, Feraheme is currently indicated only for the treatment of iron deficiency anemia in adult CKD patients.