(By Balaseshan) AMAG Pharmaceuticals Inc. (NASDAQ: AMAG) said it has submitted a supplemental new drug application (sNDA) for Feraheme (ferumoxytol) Injection for Intravenous (IV) use for inclusion of treating all iron deficiency anemia patients who cannot take oral iron.
The sNDA requests the U.S. Food and Drug Administration (FDA) approval to expand the indication for ferumoxytol beyond the current indication for the treatment of iron deficiency anemia (IDA) in adult patients with chronic kidney disease (CKD) to all adult patients with IDA who have failed or could not tolerate oral iron treatment.
The application includes data from two well-controlled phase 3 clinical trials of more than 1,400 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 tolerate oral iron treatment.
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More than 1,400 patients were enrolled in the two phase III clinical trials, IDA-301 (placebo comparator) and IDA-302 (active comparator). Both studies achieved their primary efficacy endpoints, with meaningful improvements in hemoglobin from baseline to the 35-day endpoint of the studies.
Adverse events and serious adverse events associated with IV iron therapy, including hypersensitivity reactions, were reported in both studies. No new safety signals, outside of those described in the current Feraheme label, were observed with ferumoxytol treatment in these studies. These clinical trials also included patient-reported outcomes data as pre-specified secondary and exploratory endpoints.
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These outcomes endpoints, including quantitative measures of patients' fatigue and measures of quality of life, captured the negative pre-treatment impact anemia has on these patients' lives – and the significant improvement in these scores following a one gram course of therapy with ferumoxytol.
AMAG is trading down 0.79% at $15.03 on Monday. The stock has been trading between $12.43 and $19.62 for the past 52 weeks.