FDA Expands Approval of Ferumoxytol Injection for Iron Deficiency Anemia

The FDA approved a supplemental new drug application for ferumoxytol injection to include all eligible adults with iron-deficiency anemia (IDA) who cannot tolerate or have not responded to oral iron. The drug was previously only indicated for patients with IDA and chronic kidney disease.

The decision was based on the results of two phase III trials evaluating ferumoxytol injection versus iron sucrose or placebo in patients with IDA and a randomized, double-blind, phase III trial comparing ferumoxytol injection with ferric carboxymaltose injection in 2,000 adults with IDA. In the third study, ferumoxytol injection was comparable to ferric carboxymaltose injection based on the primary composite endpoint of the incidence of moderate-to-severe hypersensitivity reactions and moderate-to-severe hypotension.

Researchers also found that ferumoxytol injection improved hemoglobin per gram of iron from baseline to week five (1.35 vs. 1.1 g/dL).

AE rates were similar across treatment groups, but the incidence of severe hypophosphatemia (defined as blood phosphorous of <0.6 mmol/L at week 2) was lower in the patients receiving ferumoxytol injection, compared with ferric carboxymaltose injection (0.4% vs. 38.7%; p value not provided). The most common AEs associated with ferumoxytol were diarrhea, headache, nausea, dizziness, hypotension, constipation, and peripheral edema.

Source: AMAG Pharmaceuticals press release, February 5, 2018.