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FDA approves Amag's intravenous Feraheme for iron deficiency anemia in patients with CKD
Wednesday, July 01 2009 | Comments
What's This?
The Food and Drug Administration approved Amag Pharmaceuticals Inc.'s Feraheme (ferumoxytol), an intravenous iron replacement therapy, for treating iron deficiency anemia in adults with chronic kidney disease (CKD).The drug's approval was based on data from three open-label, randomized safety and efficacy studies and another double-blind, randomized, placebo-controlled safety study. The primary endpoint of the three pivotal safety and efficacy studies was the mean change in hemoglobin from baseline at day 35 following the first dose; it was achieved with statistical significance in all three trials.
As compared with treatment using iron administered orally, Feraheme significantly increased hemoglobin levels across the spectrum of CKD. The company's Feraheme development program included 1,562 patients with all stages of CKD.
Two postmarketing studies are planned in pediatric patients with CKD, each of which has a planned enrollment of approximately 75 individuals. These studies are expected to begin next year.
The New Drug Application for Feraheme was originally submitted in December 2007, and the firm subsequently received two complete response letters. In the second letter, sent in December of last year, the FDA requested data to clarify an issue pertaining to a chemistry, manufacturing and controls question; the resolution of deficiencies found during a preapproval inspection of the firm's manufacturing facility; and finalization of labeling discussions. In May, the FDA accepted Amag's resubmission.
Amag also is developing Feraheme as a diagnostic agent for vascular-enhanced magnetic resonance imaging to assess peripheral arterial disease.
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