FDA Broadens Feraheme Use for Iron Deficiency Anemia
New indication goes beyond patients with chronic kidney disease
AMAG Pharmaceuticals announced that the Food and Drug Administration (FDA) has approved an expanded use for Feraheme (ferumoxytol injection) to include all eligible adults with iron deficiency anemia (IDA) who have intolerance to oral iron or have had unsatisfactory response to oral iron.
The expanded approval was based on data from two Phase 3 trials comparing Feraheme and iron sucrose in patients with IDA, as well as data from a Phase 3 randomized, double-blind, clinical safety trial (N=2,000) comparing Feraheme to Injectafer (ferric carboxymaltose injection; American Regent) in patients with IDA. In this study, Feraheme was comparable to Injectafer based on the primary composite endpoint of the incidence of moderate-to-severe hypersensitivity reactions (including anaphylaxis) and moderate-to-severe hypotension.
Feraheme, a hematinic, was initially approved by the FDA in 2009 to treat IDA in adults with chronic kidney disease (CKD). It consists of a superparamagnetic iron oxide that is coated with a carbohydrate shell, which helps isolate the bioactive iron from plasma components until the iron-carbohydrate complex enters the reticuloendothelial system macrophages of the liver, spleen, and bone. The released iron then either enters the intracellular storage iron pool (eg, ferritin) or is transferred to plasma transferrin for transport to erythroid precursor cells for incorporation into hemoglobin.
Feraheme is available as a 30mg/mL strength colloidal iron supplied in 17mL single-use vials in 1- and 10-count cartons.
For more information call (877) 411-25510 or visit Feraheme.com.