FDA accepts submission to expand Feraheme label for iron deficiency anemia

The FDA accepted AMAG Pharmaceuticals’ submission to broaden the existing label for ferumoxytol to include the treatment of all adults with iron deficiency anemia who are intolerant to or have unsatisfactory response to oral iron.

Ferumoxytol (Feraheme, AMAG Pharmaceuticals), an iron replacement product, is currently indicated for the treatment of iron deficiency anemia in adults with chronic kidney disease.

AMAG’s submission included data from a randomized, double-blind, noninferiority phase 3 clinical trial designed to compare ferumoxytol with ferric carboxymaltose injection (Injectafer, American Regent) in approximately 2,000 adults with iron deficiency anemia failed or could not tolerate oral iron, or for whom oral iron was contraindicated.

The study met its prespecified primary endpoint, as ferumoxytol demonstrated noninferiority to ferric carboxymaltose injection based on the primary composite endpoint of incidence of moderate to severe hypersensitivity reactions, including anaphylaxis, or moderate to severe hypotension.

“The acceptance of our Feraheme label extension filing marks an important milestone in our effort to bring Feraheme to the more than 4.5 million Americans who have been diagnosed with iron deficiency anemia and suffer from its debilitating effects” Julie Krop, MD, chief medical officer and senior vice president of clinical development and regulatory affairs at AMAG, said in a company-issued press release.

“A significant proportion of these patients are women with iron deficiency anemia who suffer from gynecological issues, including abnormal uterine bleeding,” Krop said. “We look forward to leveraging our deep relationships and expertise in women's health to bring a potential new treatment option to this underserved population.”

The FDA is expected to make a decision on the label expansion by Feb. 2, 2018.