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| |  FDA Approves Ferumoxytol for Iron Deficiency Anaemia in Patients With CKD NEW YORK -- June 30, 2009 -- The US Food and Drug Administration (FDA) has granted marketing approval for ferumoxytol injection (Feraheme) for intravenous (IV) use as an iron replacement therapy for the treatment of iron deficiency anaemia in adult patients with chronic kidney disease (CKD). The approval was based 3 open-label, multicentre, randomised safety and efficacy studies and a double-blind, multicentre, randomised, placebo-controlled cross-over safety study. Each of the 3 safety and efficacy studies achieved statistical significance in its primary endpoint: the mean change in haemoglobin from baseline at day 35 after the first dose. Ferumoxytol significantly increased haemoglobin levels as compared with oral iron across the spectrum of CKD. Overall, 1,726 patients were treated with ferumoxytol in the development program, including 1,562 patients with all stages of CKD. Hypotension was reported in 1.9% (33/1,726) of patients receiving ferumoxytol, including 3 patients with serious hypotensive reactions. Adverse reactions potentially associated with hypersensitivity were reported in 3.7% (63/1,726) of these patients including 0.2% (3/1,726) with serious hypersensitivity reactions. Patients should be observed for signs and symptoms of hypersensitivity for at least 30 minutes following ferumoxytol injection and the drug should only be administered when treatment of hypersensitivity reactions is readily available. Patients should be regularly monitored for haematologic response during parenteral iron therapy, noting that lab assays may overestimate serum iron and transferrin bound iron values in the 24 hours following administration of ferumoxytol. Ferumoxytol may transiently affect magnetic resonance diagnostic imaging studies for up to 3 months following the last dose. Ferumoxytol will not affect X-ray, computed tomography (CT), positron emission tomography (PET), single photon emission computed tomography (SPECT), ultrasound, or nuclear imaging. The most commonly occurring adverse reactions in ferumoxytol-treated patients versus patients treated with oral iron reported were diarrhoea (4.0% vs 8.2%), nausea (3.1% vs 7.5%), dizziness (2.6% vs 1.8%), hypotension (2.5% vs 0.4%), constipation (2.1% vs 5.7%), and peripheral oedema (2.0% vs 3.2%). Adverse reactions leading to treatment discontinuation and occurring in 2 or more ferumoxytol-treated patients included hypotension, infusion site swelling, increased serum ferritin level, chest pain, diarrhoea, dizziness, ecchymosis, pruritus, chronic renal failure, and urticaria. SOURCE: AMAG Pharmaceuticals, Inc.
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