AMAG Pharmaceuticals has submitted a supplemental new drug application (sNDA) for intravenous (IV) use of Feraheme injection, to FDA.
The company is seeking approval for the label expansion of Feraheme to include all iron deficiency anemia (IDA) patients who cannot take oral iron.
At present, Ferumoxytol is indicated for the treatment of IDA in adult patients with chronic kidney disease (CKD).
AMAG president and chief executive officer William Heiden said the approval of Feraheme for a broader IDA patient population would expand market opportunity in the existing US IV iron market, further than present CKD indication.
"We believe that Feraheme, if approved for this indication, could provide a new treatment option for patients suffering from iron deficiency anemia who cannot tolerate or do not respond to oral iron therapy," Heiden added.
The sNDA is based on positive data collected from two well-controlled phase III trials, IDA-301 and IDA-302, involving more than 1,400 adult IDA patients.