FDA approves new IV iron therapy for CKD

The drug is not yet approved for an oncology setting.

The FDA has approved ferumoxytol injection for intravenous use as an iron replacement therapy for the treatment of iron deficiency anemia in adult patients with chronic kidney disease.

Ferumoxytol (Feraheme, AMAG Pharmaceuticals) is the first new IV iron therapy approved in almost a decade, according to a company press release.

The drug was approved at a recommended dose of 510 mg IV injection followed by a second 510 mg IV injection three to eight days later. Ferumoxytol should be administered as an undiluted IV injection delivered at a rate of up to 1 mL per second (30 mg/sec).

The approval was based on results from four phase-3 studies of patients with chronic kidney disease and iron deficiency anemia. These studies included three open-label, multicenter, randomized safety and efficacy studies and one double-blind, randomized, placebo-controlled cross-over safety study.

Each of the three safety and efficacy studies met their primary endpoint: mean change in hemoglobin from baseline at day 35 after the first dose. The drug significantly increase hemoglobin compared with oral iron.

In clinical trials the most commonly occurring adverse reactions to ferumoxytol vs. oral iron were diarrhea, nausea, dizziness, hypotension, constipation and peripheral edema.

Ferumoxytol is expected to be commercially available in the second half of July 2009.

This drug is exciting. We don't know enough about it yet, but it looks like it is pretty good in chronic renal failure. There is no 1 g data on it yet, but I'll bet you that we will be able to give 1,000 or 1,500 mg of this drug in approximately five minutes, and that is going to be a huge improvement in the way IV iron is administered. However, right now since it is given as no more than 500 mg in a single injection with the next dose three to eight days later it has no advantage in oncology over the current treatment low molecular weight iron dextran, which is the only drug approved in the United States for the oncology setting.

But once the manufacturer is able to show safety data for complete replacement dosing, I think it is going to have a gigantic opportunity to become a major player. I think there is no reason to believe that higher doses of this drug aren't going to be safe.

– Michael Auerbach, MD

Clinical Professor of Medicine,
Georgetown University, Washington, D.C.