AMAG Pharmaceuticals, Inc. (AMAG) Monday said it has submitted a supplemental new drug application, or sNDA, to the Food and Drug Administration, for Feraheme Injection.
The sNDA proposes expansion of indications for the Ferahame, or ferumoxytol, injection for a treatment of iron deficiency anemia in adult patients with IDA who have failed or could not tolerate oral iron treatment.
The sNDA submission includes data from a global phase III program that evaluated the use of ferumoxytol in a broad range of adult IDA patients, all of whom had failed or could not tolerate oral iron treatment. More than 1,400 patients were enrolled in the two phase III clinical trials.
The regulatory approval of Feraheme for a broader IDA patient population would expand the company's market opportunity in the existing U.S. IV iron market, beyond its current CKD indication.
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