FDA Reviews Feraheme Label Expansion

AMAG Pharmaceuticals announced that the FDA has accepted for review its supplemental New Drug Application (sNDA) to expand the indication for Feraheme (ferumoxytol) injection for IV use to adult patients with iron deficiency anemia (IDA) who have failed or could not take oral iron treatment. Feraheme injection for IV use is currently indicated for the treatment of iron deficiency anemia in adult chronic kidney disease (CKD) patients.

The sNDA submission is based on data from a global Phase 3 program that evaluated the use of ferumoxytol in a broad range of adult IDA patients, all of whom had failed or could not take oral iron treatment. More than 1,400 patients were enrolled in the two Phase 3 clinical trials (IDA-301, a placebo comparator and IDA-302, an active comparator). Both studies achieved their primary efficacy endpoints, with statistically significant improvements in hemoglobin from baseline to the 35-day endpoint of the studies.

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