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AMAG Pharmaceuticals, Inc.
today announced that it has
submitted a supplemental new drug application (sNDA) to the United States Food
and Drug Administration (FDA) for Feraheme® (ferumoxytol) Injection for
Intravenous (IV) use. The sNDA requests 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 III
clinical trials of more than 1,400 patients.
The sNDA submission is based on 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, 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® (ferumoxytol) 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. 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.
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