FDA News

FDA expands approval of Feraheme for iron deficiency anemia

The FDA expanded the approval of ferumoxytol injection to include all eligible adults with iron deficiency anemia who have intolerance to oral iron or do not respond to oral iron.

Ferumoxytol injection (Feraheme, AMAG Pharmaceuticals) previously was only indicated for patients with iron deficiency anemia and current chronic kidney disease.

Iron deficiency anemia is a serious and undertreated 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, clinical professor at Georgetown University School of Medicine, said in a press 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 3 days apart.”

The FDA based the expanded approval on results of two phase 3 trials — which evaluated ferumoxytol injection compared with iron sucrose and placebo among patients with iron deficiency anemia — and a randomized, double-blind phase 3 trial of ferumoxytol injection compared with ferric carboxymaltose injection (Injectafer; American Regent, Daiichi Sankyo) in 2,000 adults with iron deficiency anemia.

Results showed ferumoxytol injection was comparable to ferric carboxymaltose injection based on the composite primary endpoint of incidence of moderate-to-severe hypersensitivity reactions — including anaphylaxis — and moderate-to-severe hypotension.

Researchers also found ferumoxytol injection improved hemoglobin per gram of iron administered from baseline to week 5 (1.35 g/dL vs. 1.1 g/dL).

Adverse events appeared similar across both treatment groups; however, ferumoxytol injection led to lower rates of severe hypophosphatemia (0.4% vs. 38.7%).

“An expanded Feraheme label that includes all eligible adult [iron deficiency anemia] 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 [iron deficiency anemia] market segment,” Nik Grund, chief commercial officer at AMAG, said in the release. “In addition, roughly 4.5 million Americans suffer from the debilitating effects of [iron deficiency anemia].”

The FDA expanded the approval of ferumoxytol injection to include all eligible adults with iron deficiency anemia who have intolerance to oral iron or do not respond to oral iron.

Ferumoxytol injection (Feraheme, AMAG Pharmaceuticals) previously was only indicated for patients with iron deficiency anemia and current chronic kidney disease.

Iron deficiency anemia is a serious and undertreated 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, clinical professor at Georgetown University School of Medicine, said in a press 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 3 days apart.”

The FDA based the expanded approval on results of two phase 3 trials — which evaluated ferumoxytol injection compared with iron sucrose and placebo among patients with iron deficiency anemia — and a randomized, double-blind phase 3 trial of ferumoxytol injection compared with ferric carboxymaltose injection (Injectafer; American Regent, Daiichi Sankyo) in 2,000 adults with iron deficiency anemia.

Results showed ferumoxytol injection was comparable to ferric carboxymaltose injection based on the composite primary endpoint of incidence of moderate-to-severe hypersensitivity reactions — including anaphylaxis — and moderate-to-severe hypotension.

Researchers also found ferumoxytol injection improved hemoglobin per gram of iron administered from baseline to week 5 (1.35 g/dL vs. 1.1 g/dL).

Adverse events appeared similar across both treatment groups; however, ferumoxytol injection led to lower rates of severe hypophosphatemia (0.4% vs. 38.7%).

“An expanded Feraheme label that includes all eligible adult [iron deficiency anemia] 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 [iron deficiency anemia] market segment,” Nik Grund, chief commercial officer at AMAG, said in the release. “In addition, roughly 4.5 million Americans suffer from the debilitating effects of [iron deficiency anemia].”