FDA Expands Indication for Anemia Drug Feraheme

Megan Brook

February 06, 2018

The US Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for the anemia drug ferumoxytol injection (Feraheme, AMAG Pharmaceuticals) beyond the current chronic kidney disease indication to include all eligible adults with iron deficiency anemia (IDA) who can't tolerate or have failed to respond adequately to oral iron, the company said.

Approval of the sNDA was supported by two phase 3 studies evaluating ferumoxytol injection versus iron sucrose or placebo in a broad population of patients with IDA and a third phase 3 study comparing ferumoxytol injection with ferric carboxymaltose injection in patients with IDA. In this 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.

The study also met key 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 with ferumoxytol vs 1.10 g/dL with ferric carboxymaltose).

Adverse event rates were similar across both treatment groups; however, severe hypophosphatemia was less common in the patients receiving ferumoxytol injection than in those receiving ferric carboxymaltose injection.

"Iron deficiency anemia is a serious and under-treated health condition which negatively impacts quality of life for millions of people, many of whom do not benefit from or cannot tolerate oral iron therapy," Michael Auerbach, MD, from Georgetown University School of Medicine in Washington, DC, said in a company news release.

"Physicians now have a new option for patients who meet the broader ferumoxytol injection indication that can be administered in 15 minutes providing a gram of iron in two doses as few as three days apart," Dr Auerbach added.

The most common adverse reactions (≥ 2%) with ferumoxytol are diarrhea, headache, nausea, dizziness, hypotension, constipation, and peripheral edema.

Fatal and serious hypersensitivity reactions including anaphylaxis have occurred in patients receiving ferumoxytol. Initial symptoms may include hypotension, syncope, unresponsiveness, and cardiac/cardiorespiratory arrest. Hypersensitivity reactions have occurred in patients in whom a previous ferumoxytol dose was tolerated.

Ferumoxytol is contraindicated in patients with known hypersensitivity to ferumoxytol or any of its components, or a history of allergic reaction to any intravenous iron product.

Full prescribing information is available online.

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