AMAG Pharmaceuticals Inc. has received FDA approval to broaden the existing label for its iron drug Feraheme to include all eligible adults with iron deficiency anemia. The drug is already indicated for use in patients with chronic kidney disease and end-stage renal disease.
“An expanded Feraheme label that includes all eligible adult [iron deficiency anemia] IDA patients will double the addressable market opportunity estimated to be nearly a million patients per year for Feraheme and provide for future growth within this broader IDA market segment,” Nik Grund, chief commercial officer at AMAG, said in a press release.
According to the release, the label expansion was approved after two phase 3 trials evaluating Feraheme (ferumoxytol injection) vs. iron sucrose or placebo in a broad population of patients with IDA. It was also supported by results from a third phase 3 randomized, double-blind, clinical safety trial that compared the drug to Injectafer (ferric carboxymaltose injection, Vifor Inc.) in approximately 2,000 adults with IDA.
“The study demonstrated comparability to Injectafer based on the primary composite endpoint of the incidence of moderate-to-severe hypersensitivity reactions (including anaphylaxis) and moderate-to-severe hypotension,” the company reported. “The study also met important secondary safety and efficacy endpoints, including the demonstration of mean improvement in hemoglobin per gram of iron administered from baseline to week 5 (1.35 g/dL Feraheme vs. 1.10 g/dL Injectafer).”