AMAG Pharmaceuticals, Inc.
AMAG today announced that it has commenced start-up activities for
its head-to-head Phase 3 clinical trial evaluating the safety of Feraheme(R)
(ferumoxytol) compared to Injectafer(R) (ferric carboxymaltose injection) in
adults with iron deficiency anemia (IDA).
The planned safety trial follows the Complete Response Letter (CRL) AMAG
received from the U.S. Food and Drug Administration (FDA) in January 2014
regarding its supplemental new drug application (sNDA) to broaden the use of
Feraheme beyond the current chronic kidney disease (CKD) indication to
include all adult IDA patients who have failed or cannot tolerate oral iron
treatment.
"We have worked closely with the FDA to develop a path forward for
potentially broadening the indication for Feraheme to include all patients
with iron deficiency anemia. This safety trial represents a significant step
forward in that process," said Dr. Julie Krop, chief medical officer and
senior vice president of clinical development and regulatory affairs at
AMAG. "Approximately 4.5 million Americans suffer from the debilitating
effects of IDA, and we believe healthcare providers need additional
treatment options to help care for their IDA patients."
The randomized, double-blind, multicenter non-inferiority trial will
evaluate the incidence of moderate to severe hypersensitivity reactions
(including anaphylaxis), and moderate to severe hypotension with Feraheme
compared to ferric carboxymaltose injection in adults with IDA. Two thousand
patients will be randomized in a 1:1 ratio into one of two treatment groups
-- 1.02 grams of Feraheme intravenous (IV) infusion or 1.5 grams of ferric
carboxymaltose injection. While the trial's primary endpoint is safety, the
study will also assess efficacy.
"Moving forward with this head-to-head clinical trial to support potential
FDA regulatory approval for a broader indication of Feraheme highlights our
commitment to not only the IDA community but also to maternal health," said
William Heiden, chief executive officer of AMAG. "Today, 1.5 million of the
4.5 million Americans already diagnosed with IDA are women with abnormal
uterine bleeding, or who are pregnant or post-partum. Many of these women
are under the care of the obstetricians who are called upon by our maternal
health commercial team. We believe an expanded indication would allow us to
help these women, as well as other patients whose IDA has not been
successfully treated with oral iron."
AMAG expects to begin enrolling patients in the trial in the first quarter
of 2016, with a potential sNDA approval and launch in 2018.
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