A Phase III, Randomized, Multicenter, Double-Blind, Safety Study of Ferumoxytol Compared to Ferric Carboxymaltose for the Treatment of Iron Deficiency Anemia (IDA).

Trial Profile

A Phase III, Randomized, Multicenter, Double-Blind, Safety Study of Ferumoxytol Compared to Ferric Carboxymaltose for the Treatment of Iron Deficiency Anemia (IDA).

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 31 Aug 2017

At a glance

  • Drugs Ferumoxytol (Primary) ; Ferric carboxymaltose
  • Indications Iron deficiency anaemia
  • Focus Adverse reactions; Registrational
  • Acronyms FIRM
  • Sponsors AMAG Pharmaceuticals
  • Most Recent Events

    • 31 Aug 2017 According to an AMAG Pharmaceuticals media release, the U.S. Food and Drug Administration (FDA) accepted its submission to broaden the existing label for Feraheme (ferumoxytol) to include the treatment of all adults with iron deficiency anemia (IDA) who have an intolerance or unsatisfactory response to oral iron. The FDA has indicated a six-month review timeline and established a Prescription Drug User Fee Act target action date of February 2, 2018. Data from this trial supported the submission.
    • 03 Aug 2017 According to an AMAG Pharmaceuticals media release, AMAG Pharmaceuticals has completed the submission to the U.S. Food and Drug Administration (FDA) to broaden the existing label for Feraheme (ferumoxytol) to include the treatment of all adults with iron deficiency anemia (IDA) who have an intolerance or unsatisfactory response to oral iron. AMAG anticipates an FDA decision on the filing in the first half of 2018.
    • 02 May 2017 Top-line results from this trial published in an AMAG Pharmaceuticals media release.
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